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  • Novel Targets for the Development of Monoclonal Antibodies for Immunotherapy)

    Phase

    N/A

    Span

    170 weeks

    Sponsor

    Checkmab S.r.l.

    Milan

    Recruiting

    Healthy Volunteers

  • FDG-PET/CT vs. CT for Monitoring Metastatic Breast Cancer

    Background Breast cancer is the most commonly diagnosed cancer in Europe and worldwide. With a continuously increasing incidence, it is estimated that by 2040, the breast cancer burden will increase to more than three million new cases per year worldwide, with more than one million breast cancer-related deaths per year (50% increase). The prognosis of breast cancer is steadily improving due to the early detection of primary cancer through screening programs and revolutionising treatment development. Despite this, approximately one-third of patients diagnosed with primary breast cancer will develop metastatic disease. In the metastatic setting, therapy improvements have made breast cancer a chronic disease with declining mortality rates, and several effective treatment lines are available for metastatic breast cancer patients today and in the future. This favourable situation requires accurate methods to assess response to treatment to achieve the most effective treatment planning. FDG-PET/CT is increasingly used in cancer staging. Several studies have shown improved sensitivity of FDG-PET/CT compared with conventional imaging for diagnosing metastatic breast cancer in retrospective and smaller prospective studies. We expect FDG-PET/CT to detect disease progression earlier than CT in patients treated for metastatic breast cancer, enabling earlier start of second-line therapies. This has the potential to increase the beneficial effect of second-line therapies at the individual level and result in a delayed need for third-line therapies, prolonged overall survival, and improved quality of life compared with patients monitored with conventional CT. Currently, no specific recommendations are provided for a diagnostic modality to monitor treatment response in patients with metastatic breast cancer. European clinical practice guidelines (ESMO) state that there is no evidence of any staging or monitoring approach for metastatic breast cancer patients that provides overall survival benefit over another approach. ESMO suggests that FDG-PET/CT might provide earlier guidance in the monitoring of bone-only or bone-predominant metastasis, but it is emphasised that prospective trials are needed to study the impact of this on treatment decisions and overall survival. This is the evidence that MONITOR-RCT will deliver. Study objectives The primary objective of the MONITOR-RCT is to demonstrate that in patients with metastatic breast cancer, response monitoring based on FDG-PET/CT is superior to response monitoring based on CT with respect to overall survival. The objective will be based on applying standardized response evaluation criteria, using an appropriate adaptation of the PERCIST criteria for FDG-PET/CT and the RECIST1.1 criteria for CT. Secondary objectives of the MONITOR-RCT are to demonstrate superiority with respect to the quality of life and exposure to oncologic treatment and to investigate the cost-effectiveness. Consequently, the primary endpoint of the study is overall survival. Secondary endpoints are quality of life, exposure to oncologic treatment, and cost-effectiveness. Study design The MONITOR-RCT study will be an international multicenter study. The design will be a parallel group comparative randomized trial comparing an experimental monitoring strategy based on FDG-PET/CT with a standard monitoring strategy based on CT. Eight hospital sites in Denmark, two in Italy, and one in Germany will participate in patient recruitment and the conduction of the study. Inclusion criteria Criteria for inclusion will be: Women and men aged ≥18 years Diagnosis of distant relapsed metastatic breast cancer (biopsy-verified) or de novo breast cancer. In patients with distant relapsed metastatic breast cancer, biopsy verification from a distant metastasis is required. In patients with de novo metastatic breast cancer, biopsy verification of primary tumor and diagnostic imaging with distant metastasis with a typical pattern of metastatic breast cancer is required. Considered eligible for first-line systemic treatment Considered eligible for continuous treatment monitoring by scans. Signed informed consent Participants must have the ability to read and understand the following languages based on their country of participation: in Denmark, patients must be able to read and understand Danish; in Italy, they must be able to read and understand Italian or English; and in Germany, they must be able to read and understand German or English. Exclusion criteria Criteria for exclusion will be: Pregnant or lactating women Ongoing oncological treatment for another cancer Exclusively brain metastasis Allergy to FDG Target population Participating patients should have newly diagnosed metastatic breast cancer and be considered eligible for initiating first-line medicinal treatment and subsequent regular response monitoring. This is the patient population for whom a benefit from FDG-PET/CT-based response monitoring is expected. They are very similar to the criteria defining the populations investigated in Vogsen et al. (2023) and Naghavi-Behzad et al. (2022). Quality of life questionnaires Quality of life questionnaires will be completed at home every three months during the first year and every six months later. Two questionnaires will be used: EQ-5D-5L FACT-B In addition, patients can report complaints related to the conduct of scans in a final open question at the end of the questionnaires. Interventions The intervention of interest is the use of FDG-PET/CT for response monitoring compared with CT for response monitoring. The use of CT as a monitoring modality represents the usual care in patients with metastatic breast cancer. FDG-PET/CT scans will be evaluated using the standardized response evaluation criteria for patients with metastatic breast cancer (PREMIO criteria), whereas the CT scan will be evaluated using the RECIST 1.1 criteria. Both criteria aim at classifying the patient as having complete (metabolic) response (CR/CMR), partial (metabolic) response (PR/PMR), stable (metabolic) disease (SD/SMD), equivocal metabolic disease (EMD) or progressive (metabolic) disease (PD). The PREMIO set of response evaluation criteria is an adaptation of PERCIST (for monitoring patients with metastatic breast cancer. The PREMIO criteria are defined based on data from the MESTAR study, Vogsen et al. (2023), introducing the nadir scan for comparison in cases where the disease has regressed compared with the baseline scan. Clinical decision-making: For patients in the intervention group, clinical decision-making will be supported by FDG-PET/CT and PREMIO, while the conventional group will be supported by the CE-CT and RECIST 1.1. The decision-making will be in both groups following the current standard according to the local practice and following international guidelines. The decision-making may include a request for further imaging procedures. Parameters such as toxicity profile and the patient's general condition will also influence treatment decisions. Major components of patient management and the main reasons for treatment decisions will be registered throughout the study. Scan procedure and interpretation: All patients will have baseline scans performed before treatment and according to the randomization group. Treatment and follow-up scans will be approximated at regular intervals of 9-12 weeks or according to local guidelines. The choice of the diagnostic modality does not influence the monitoring intervals or time points. Contrast-enhanced CT of at least the thorax and abdomen will be performed using diagnostic scan quality. Pelvic CT may be added based on clinical need. The scan reports will be made by specialists in radiology with an assessment according to the RECIST 1.1 criteria. FDG-PET/CT will follow standard guidelines from the European Association of Nuclear Medicine. FDG-PET/CT scans will be conducted on EARL2 certified PET scanners, and the quantitative assessment, using the SULpeak value of the hottest metastatic lesion, will based on the EARL2 reconstruction. The CT performed along with the PET scan will be of diagnostic quality and will have contrast enhancement, if not contraindicated. The scans will be assessed by specialists in nuclear medicine according to the suggested PREMIO criteria. According to RECIST 1.1 and PREMIO, disease measurability will be evaluated at the baseline and during follow-up in each study group. In cases of no measurable disease according to the respective criteria applied, the patient's scans will be assessed qualitatively with a parallel response categorization. This categorization slightly differs from the one used in the case of measurable disease, but it still allows for the distinction of progressive disease from all other states. CT and FDG-PET/CT scans will be viewed based on the existing standard software. Viewing of FDG-PET/CT scans will be further supported by software developed as part of the establishment of the PREMIO criteria. Application of the criteria remains a task for radiologists or nuclear medicine specialists. Outcome variables The primary endpoint "Overall survival" will be addressed based on the primary outcome variable "Time from randomization until death". The secondary endpoint "Quality of life" will be addressed by two outcome variables. The first is the overall summary score of the FACT-B, the second the complaints related to the conduct of scans reported by the patients. The secondary endpoint "Exposure to oncologic treatment" will be addressed by the following outcome variables describing different aspects of oncological treatment: Experience of progression Start of a new treatment line because of progression Time to first progression Time from first to second progression Time from second to third progression Experiencing other diagnostic procedures Hospitalization The secondary endpoint "Cost-effectiveness" will be addressed based on relating the outcome variables "Overall survival" and "Quality of Life" to the outcome variable "Costs". These outcome variables correspond to the expected benefits described above. Sample size considerations Sample size considerations are based on using a direct comparison of the survival rates at 42 months. The statistical test finally used will be more powerful due to summarizing the information from all time points and adjustment for prognostic covariates. In the study of Naghavi-Behzad et al. (2022), the survival rate after 42 months was 34% in the CT group and 51% in the FDG-PET/CT group. Due to the introduction of new, more effective treatment lines in the last decade, we expect higher survival rates in this RCT. Sample size calculations are based on the assumption that true survival probabilities will be 39% and 56%, respectively. Under this assumption, we have to include overall 420 patients to reach a power of 87% (based on two-sided testing at the 5% level). According to the timeline of the study, the minimal (planned) follow-up time of the patients will be 36 months, and the maximal follow-up time will be 54 months. In the above calculations, a uniform distribution of the follow-up time was assumed. With respect to the primary outcome (survival), we do not expect drop outs, as we can rely also on national registries. Hence drop-outs are not accounted for in the sample size calculation. Significance level A significance level of 5% (two-sided) will be applied. Exposure to radiation The radiation dose is an issue of consideration. The average radiation dose per patient per scan procedure is estimated, in conventional diagnostic CT, to be 9 mSv and in conventional 18F-FDG-PET/CT to an additional 4 mSv, respectively.

    Phase

    N/A

    Span

    213 weeks

    Sponsor

    Odense University Hospital

    Milan

    Recruiting

  • APACE - Feasibility of Using Accelerometers to Measure Physical Activity in Cancer Patients on Early Phase Clinical Trials

    Phase

    N/A

    Span

    96 weeks

    Sponsor

    University of Manchester

    Milan

    Recruiting

  • Study on Blood Pressure Variability and Frailty in the Older People

    Observational prospective single-center, non-profit study. Primary objective of the study: To determine if the hypotensive phenotype, defined as one episode of daytime systolic blood pressure (SBP) <90 mmHg (or two episodes of daytime SBP <90 mmHg, if mean 24 h SBP is <125 mmHg) detected at Ambulatory Blood Pressure Monitoring (ABPM) is associated with adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events) Secondary objectives of the study: - To examine the association between home Blood Pressure Variability (BPV) and frailty, assessed using various tools for assessing frailty - To examine the association between short term BPV and adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events) - To determine the prevalence of hypotensive phenotype according to frailty status in hypertensive individuals.

    Phase

    N/A

    Span

    157 weeks

    Sponsor

    Istituto Auxologico Italiano

    Milan

    Recruiting

  • Saliva and Extracellular Vesicles for Neurodegenerative Diseases

    BACKGROUND: Neurodegenerative diseases (NDDs) are a miscellaneous group of disorders that variably affect individuals, with many subtle distinctions and different speeds across individuals and syndromes. The evolution of NDDs involves cognition, behavior and motor domains of clinical assessment that result in lifelong functional and social impairments with high economic and social costs. The biochemical pathophysiological drivers occur far earlier than symptoms appearance making the identification of subjects with preclinical disease the basis for early diagnosis, needed for an effective therapy. The clinical definition of NDDs is basically insufficient, but the molecular signals from the brain can lead to the identification of a biomarker that can be measured periodically in a non-invasive way. Therefore, a disease-specific biomarker is needed. The possibility of identifying specific markers for NDDs within saliva has recently emerged. Saliva and salivary Extracelluler Vesicles (sEVs) are vehicles for molecules associated with neuronal damage and neuroinflammation. Their isolation allows an enrichment of the molecules involved in the pathogenetic mechanisms of NDDs, improving their quantification. Raman spectroscopy (RS) is a method useful for the exhaustive biochemical characterization of saliva and its vesicular component, without staining and labeling procedures, highly informative, rapid and sustainable. In a rapid, sensitive and non-destructive way, RS provides with a spectrum that can be used as a highly specific "fingerprint" for the selected sample (e.g. saliva, blood, EV) representing the diagnostic biomarker itself. The RS study of saliva has already demonstrated the possibility of profiling patients with progressive pathologies with good accuracy and, specifically, of distinguishing subjects suffering from NDDs, with no further investigation of the ability to distinguish the NDDs at an early stage, the verification of the possibility to monitor its progression, nor the investigation of the biomolecular moieties involved in the observed differences. Raman spectroscopy is proposed as a reliable method for the rapid and exhaustive biochemical characterization of salivary and vesicular component present in the sample, without the need for staining or labeling procedures. OBJECTIVES: The objective of this project is the validation of a Raman molecular fingerprint for the considered exerimental groups, leading to the identification of a complex biomarker useful for 1) the early identification, 2) phenotyping and 3) molecular profiling of subjects with NDDs, leading to the prompt identification of tailored therapeutic strategies, including optimal pharmacological and rehabilitation therapies for each subject, with a significant impact on patients' quality of life and, in the future, on the increased probability of slowing down the progression of NDDs with optimal effective therapies. At a national level, early personalized intervention can reduce patient management times and costs. SAMPLE SIZE: Sample size was calculated with G-Power (medium effect size f=0.25, statistical power 85%, a=0.05, for ANOVA omnibus statistical test with 5 experimental groups AD, PD, AtP, pPD, MCI, drop-out rate of about 10%). The minimum number of subjects to be involved is 242. Considering the different incidence of the considered NDDs, distribution is not equal among groups. DATA COLLECTION: Demographic, clinical and research data will be pseudonymized and stored in a custom made REDCap database. NDDs diagnosis (AD, PD, AtPD, pPD or MCI), demographic (age, sex), clinical history, and comorbidities (Cumulative Illness Rating Scale) data will be stored. Saliva will be collected using an optimized protocol. SAMPLE COLLECTION: At recruitment (T0), at least 60min after the intake of food and/or drinks, saliva will be collected using Salivette tubes(Starstedt®). After 12 months(T12), subjects will be asked for a second saliva sample. Pre-analytical parameters, dietary and smoking habit will be recorded. Samples will be frozen until used. SAMPLE BIOMOLECULAR EVALUATION: SiMoA technology will be used to quantify NDDs related markers: asyn for PD, AtP and pPD, Aβ1-42 for AD and MCI, NfL as general biomarkers of neurological damage in all groups. EV ISOLATION AND CHARACTERIZATION: Saliva will be used for the isolation of EVs by Size Exclusion Chromatography (SEC) and by ultracentrifugation. Effective isolation will be verified with dot blot for protein markers, Nanoparticle Tracking Analysis (NTA) for size distribution and Transmission Electron Microscopy for morphology. RAMAN ANALYSIS: Salivary and saliva derived EV spectra will be acquired using an Aramis Raman microscope (Horiba Jobin-Yvon, France) equipped with a laser light source operating at 785 nm and 532 nm (Carlomagno et al., Frontiers, 2021; Mangolini et al., Biology, 2023). DATA PROCESSING: Acquired spectra will be baseline corrected and normalized by unit vector, to homogenize the dataset using the LabSpec6(i.e. baseline, normalization). Multivariate analysis will be used to create a classification model for AD, PD, AtPD, pPD and MCI at T0, obtaining the dispersion of the Canonical Variables. The accuracy, specificity and sensitivity of saliva and sEV RS will be calculated after the Leave-One Out Cross-Validation (LOOCV). ROC curve will be calculated. Data obtained from the molecular profiling of NDDs patients and the Raman databases will be used to interpret the spectral variation in the different experimental groups. The correlation between Raman biomolecular and clinical data will be performed to evaluate the ability of the Raman platform to stratify patients at different disease stages. The changes in the RS fingerprint between T0 and T12 will be investigated (longitudinal study) and correlated with the changes in the clinical scale scores.

    Phase

    N/A

    Span

    151 weeks

    Sponsor

    Fondazione Don Carlo Gnocchi Onlus

    Milan

    Recruiting

  • Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance

    Phase

    N/A

    Span

    256 weeks

    Sponsor

    Università Vita-Salute San Raffaele

    Milan

    Recruiting

  • Unraveling Active Ingredients of Neurorehabilitation: Investigating Cortical Activity During Task-oriented Exercises

    Phase

    N/A

    Span

    100 weeks

    Sponsor

    Fondazione Don Carlo Gnocchi Onlus

    Milan

    Recruiting

    Healthy Volunteers

  • Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

    Women who agree to participate in the study will be randomized into two groups: one group will receive standard IVF protocols, and the other will undergo a 12-week anti-inflammatory diet followed by the standard IVF protocol. In both groups, participants' dietary habits will be monitored throughout the study period to detect any variations. The primary outcome will be to compare the rate of inadequate ovarian response to hormonal stimulation (defined as the retrieval of ≤3 oocytes according to the Poseidon 2016 criteria) in infertile women with endometriosis.

    Phase

    N/A

    Span

    249 weeks

    Sponsor

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    Milan

    Recruiting

  • A Study of BMS-986504 in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion

    Phase

    2

    Span

    344 weeks

    Sponsor

    Bristol-Myers Squibb

    Milan

    Recruiting

  • Interactive Mirroring Games wIth sOcial Robot (IOGIOCO) and Robotic System Adapted Into a Clinical Scale (RISCALE)

    Background: The importance of early intervention in Autism Spectrum Disorders (ASD) has been widely demonstrated, and developmental trajectories in ASD highlight the importance of nonverbal communication, such as intransitive gesture production, as a possible positive prognostic factor for language development. The use of technological tools in the therapy of individuals with ASD has also become increasingly important due to their increased engagement and responsiveness to technological objects, such as robots. We developed a training protocol using the humanoid robot NAO, called IOGIOCO (Interactive mirroring Games wIth sOCial rObot), based on the use of intransitive gestures embedded in naturalistic dialogues, stimulating a triadic interaction between child, robot and therapist. The training is divided into six levels; the first 2 levels were called "familiarization levels," and the other 4 were "training levels". The technological setup includes different complexity levels, from mirroring tasks to building spontaneous interactions. We previously tested the protocol on 10 preschool children with ASD (aged 2-6 years) in a pilot study founding promising results (Annunziata et al,2024). We therefore developed a Randomized Controlled Trial to test the efficacy of this intervention. The primary objective of the RISCALE study is to evaluate the effectiveness of NAO training in improving socio-communicative skills and acquiring communicative gestures using the ECSP-I scale as the primary outcome measure. A second objective stems from the technological experience acquired in these two years on the development of methods for the quantitative recording of social interaction (child-operator, child-NAO gaze contact, joint attention...). 2 scenarios have been identified in the scale that can be achieved both with the human operator and through the action of NAO: - the response to the adult's gesture of indication; - the differential response - Joint Attention and/or Behavior Regulation - to the activation of a mechanical toy). The two scenarios will be videotaped with Kinect equipment and measurable data will be acquired for quantitative analysis. The procedure will be validated on a sample of typically developing children (about 20); adapted and validated the instrument on the sample of typically developing children, then the administration and then the validation of the setup obtained on subjects with Autism Spectrum Disorder will take place. The aim is to evaluate whether and how the modes of visual exploration and joint attention change and/or differ pre- and post-training, and the differences that may be evident in the modes of interaction between child and operator and between child and robot. In time, therefore, the following will be provided: 1. to set, adapt and subsequently validate the video recording setting with the identification of the quantitative parameters detectable through technological tools (ECSP-I_rob) on a sample of typically developing children aged between 18 and 24 months 2. to set, adapt and subsequently validate the video recording setting with the measurement of the quantitative parameters detectable through technological tools (ECSP-I_rob) on a sample of children with Autism Spectrum Disorder under the age of 72 months 3. start training with NAO on a group of children with ASD aged 24-72 months with pre- and post-treatment ECSP-I administration. Objectives 1. To evaluate the effectiveness of the robot-based intervention on social-communicative skills and in the acquisition of intransitive gestures used for communicative purposes using the ECSP-I and the MacArthur questionnaire as an outcome measure. The rationale remains the one already detailed in the previous phase, namely that ASD children tend to have greater difficulty in paying attention to the variability and multiplicity of signals characterizing human social interaction (e.g. mimicry, gestures...), an aspect that could lead to a possible lower interest in interaction with an individual than in a technological object towards which they would seem more attentive, responsive and quick in response 2. identify and describe measurable parameters of "social" interaction within the rehabilitation session with NAO and operator and verify their evolution and differences at the beginning and end of treatment and between the different social partners. Translationality The present study will allow to verify the feasibility and usability of the experimental evaluation protocol based on the use of the social robot NAO. If its validity is demonstrated, this method could help to make habilitative interventions in children with ASD more motivating and effective, favoring the generalization of the skills acquired in the context of daily life. Methodology Study design Multicenter Experimental Randomized Open-Label Controlled Study Type of study Low-risk experimental study Case studies Phase 1: 20 typically developing children aged 18-24 months for ECSP-I_rob data acquisition (videotaped ECSP-I administration) Phase 2: 10 ASD children - videotaped ECSP-I administration Phase 3: 20 children diagnosed with ASD aged between 24 and 72 months, already in charge for rehabilitation treatment, who will subsequently be divided into two groups for treatment. Sample Recruitment The 20 typically developing children will be recruited for adaptation and validation of the ECSP-I scale to the NAO interaction system on a voluntary basis at the NEARLab of the Politecnico di Miano and will be evaluated by a properly trained TNPEE of Fondazione Don Gnocchi Children with ASD will be recruited from among the subjects who belong to the outpatient clinics or outpatient rehabilitation treatments at IRCCS Fondazione Don Gnocchi. The sample will be recruited sequentially among children in charge for rehabilitation treatment, who have a diagnosis of Autism Spectrum Disorder confirmed with the main gold-standard tools. Sample size The calculation of the sample size is based on the primary objective of the study, i.e. the evaluation with the ECSP-I scale of the treated group and the control group. Using the Mann-Whitney Test for independent samples to compare the two groups, with a standard deviation estimate of 0.56 and a study design with a 1:1 ratio between the treated group and the control group, it is calculated that a sample of 10 subjects from each group is required to highlight an expected difference of 0.8 points on the scale with a study power of 80% and a level of significance of 5%. Statistical analysis A sequential design will be adopted for the comparison between the two groups. The adoption of this design will allow to obtain a sample of 20 participants for pre- and post-training comparison and to offer the training provided for the experimental group (group A) also to the initially control group (group B) without substantial burdens for the standard therapy procedure; it will also allow to verify the change due exclusively to the passage of time and standard therapy (T0 and T1 comparison for group B) and to carry out a follow-up (T1 and T2 comparison for group A). We also expect greater adherence to the trial, as parents would be enticed to participate by inclusion in an additional pathway to standard therapy (and not simply participation as a control group). Given the expected number of participants, and the scores of the ECSP-I scale that are expressed in ordered categories (Optimal Levels), the comparison between the measurements provided for by the sequential design (T0, T1 and T2) will be carried out with non-parametric statistical tests: - Wilcoxon Exact Test, for longitudinal comparison of each group. - test for independent samples in the exact form test for independent samples in the exact form (Mann-Whitney Exact Test), for the comparison between the experimental group and the control group. - The 2 groups will also be compared through a multivariate analysis, conducted by applying the ANCOVA model adjusted for months of age and baseline scale values to correct for potential imbalances due to the low sample size. Procedures Phase 1: ADMINISTRATION OF ECSP-I SCALE on a typically developing sample The 20 typically developing children will be recruited for the adaptation and validation of the two scenes of the ECSP-I scale to the NAO interaction system on a voluntary basis at the NEARLab of the Politecnico di Miano and the scale will be administered by a properly trained TNPEE of Fondazione Don Gnocchi Phase 2: ADMINISTRATION OF THE ECSP-I SCALE and robot-adapted scenes to a sample of children with ASD The ECSP-I scale and scenes adapted to the social robot will be administered to a sample of children with Autism Spectrum Disorder in order to gain experience and collect data about the administration of this scale to a clinical sample of 10 children. The administration will be videotaped and encoded with the supervision of the developers. Phase 3: Recruitment and randomization of the sample of children with ASD. 20 children with Autism Spectrum Disorder will be recruited, subjected to T0 assessment. Phase 4: The sample will then be divided into two groups: - a group A and group B, which will carry out training with the social robot (see Appendix A for the training protocol) at 2 different times. Phase 5: All the recruited sample will be subjected, at different times, to rehabilitation training with NAO following the protocol in the Appendix. The training will last 12 weeks, with one session per week, lasting 20-30 minutes. Phase 6: Re-evaluation to T1 and T2 according to the treatment scheme (see Table 3). Evaluation tools - Griffiths Mental Development Scales III ed (GMDS-III) [30] - Adaptive Behavior Assessment System II ed (ABAS II) [31] - Autism Diagnostic Observation Shedule (ADOS 2) [32, 33] - Autism Diagnostic Interwiev Revised (ADI-R) [34] - McArthur-Bates Questionnaire, First Vocabulary of the Child (PVB) Gestures and Words: total number of gestures [35] - Early Social Communication Scale (ECSP-I) [27] - Adapted scenes of the ECSP-I with NAO Social Robot (ECSP-I_rob) (quantitative measurement of interaction data) Criticality The main critical issue concerns the recruitment of subjects and their availability during the study period and the continuity of the intervention. For this reason, an extended recruitment period has been hypothesized, which will cover a large part of the entire duration period of the study. Expected results - Verification of the sensitivity of the ECSP-I in grasping the improvement of socio-communicative skills, in particular in the use of gestures. - Improvement in the use of gestures learned during training, in terms of: - Correctly learned gestures used in the therapeutic setting in known scenarios; - Learned gestures correctly used in the therapeutic setting in new scenarios (first step of generalization); - Increase in the number of gestures used in daily life (second phase of generalization; Mc Arthur questionnaire); - Measurement of social interaction parameters detectable with technological tools.

    Phase

    N/A

    Span

    99 weeks

    Sponsor

    Fondazione Don Carlo Gnocchi Onlus

    Milan

    Recruiting

    Healthy Volunteers

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