Lile Cedax, France
Evaluation of the Inflammation-based Index as a Predictive Marker of Clinical and Radiological Response in Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour
Phase
N/ASpan
312 weeksSponsor
Institut Claudius RegaudLille
Recruiting
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients with Homozygous Familial Hypercholesterolemia
This is a multicenter, international, long-term observational study investigating the real-world impact of lomitapide on Major Adverse Cardiovascular Events (MACE) in patients with Homozygous Familial Hypercholesterolemia (HoFH). Study Design: Observational, open-label, retrospective and prospective study Data will be collected from >26 lipid centers across Europe Patients will serve as their own control, with comparisons between pre-treatment (3 years before lomitapide) and post-treatment (first 3 years of lomitapide therapy) periods Study Population: Approximately 72 adult patients (≥18 years) diagnosed with HoFH Patients must have received lomitapide for at least 12 months Availability of 3 years of pre-treatment clinical records Objectives: Primary Objective: Evaluate the incidence of MACE before and after lomitapide treatment Secondary Objectives: Assess changes in LDL-C, total cholesterol, liver function tests (ALT, AST, GGT), and lipid-lowering therapy usage (e.g., discontinuation of LDL apheresis, addition of PCSK9 inhibitors) Endpoints: Primary Endpoint: Change in MACE incidence over the 3-year treatment period Secondary Endpoints: Changes in lipid levels, liver safety markers, and adherence to treatment protocols Safety Considerations: The study follows real-world clinical practice, with monitoring of adverse events, including liver-related safety concerns associated with lomitapide Data will be collected in an electronic Case Report Form (eCRF) and analyzed following Good Clinical Practice (GCP) guidelines This study aims to generate real-world evidence on the cardiovascular impact of lomitapide in HoFH patients, addressing an unmet clinical need for data on long-term outcomes.
Phase
N/ASpan
121 weeksSponsor
Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)Lille
Recruiting
European Registry of Next Generation Imaging in Advanced Prostate Cancer
This registry is intended to collect real-world data on patient demographics, medical history, clinical endpoints, histological tumour characteristics and imaging explorations of the patients with prostate cancer at high risk for harbouring metastatic deposits at the hormone-sensitive stage, who require imaging exploration (conventional, NGI, or their combination) either at the diagnostic workup of a "naïve" patient or at biochemical relapse/progression after local treatment. Stage 1: cross-sectional observation 1. To identify the proportion of patients for whom an imaging work-up with NGI at baseline may result beneficial, according to physician criteria. 2. Assess management prompted by NGI vs. conventional imaging in usual clinical practice. 3. To identify the proportion of patients for whom conventional imaging is considered informative enough for making a clinical decision, according to physician criteria. 4. Stratification of metastatic prostate cancer patients by the number, volume, and location of deposits, according to the different imaging tools employed. 5. Reclassification of HSPC (M0 vs low vs. high volume) based on NGI respect to CI when both imaging modalities are used. Stage 2: longitudinal observation 1. Evaluation of survival outcomes and their relationship with the imaging pathway undertaken (overall and per subgroup of imaging modality). 2. Identification of prognostic factors related to treatment response and disease progression.
Phase
N/ASpan
119 weeksSponsor
Fundacio PuigvertLille
Recruiting
Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer:
Impact of stimulation of parasympathetic activity by transcutaneous auricular vagus nerve stimulation (taVNS) on quality of life (QoL) relating to digestive symptoms in patients undergoing first-line treatment for ovarian cancer, as compared to shame taVNS Randomization between: - Experimental group: transcutaneous auricular vagus nerve stimulation (taVNS) - Control group: placebo using the same device that does not deliver electrical stimulation
Phase
3Span
179 weeksSponsor
Centre Francois BaclesseLille
Recruiting
Visual (Path)Ways in Multiple Sclerosis - Part II
Phase
N/ASpan
65 weeksSponsor
University Hospital, LilleLille
Recruiting
Prospective Cohort Study of Protected Children
A significant number of children are abused or neglected every year. This exposure is associated with short- and long-term consequences for their mental and somatic health, making child abuse a real challenge for society, both on an individual level, in terms of equal opportunities, and on a collective level, from a public health and economic point of view. In France, 308,000 minors benefit from at least one child protection service or measure. There are few data available on the health status of this population and its evolution over time, but they all point to the poor health status of children when first placed into care, with a particularly high prevalence of mental disorders, a low proportion of children benefiting from an initial health check-up, and poor quality of medical follow-up once in care. In this context, interventions are needed to address early and comprehensively the many needs of children put into care, both in the short and long term. In particular, early detection and reduced delays in the initiation of appropriate medical care appear to have positive long-term effects, reducing medico-social needs. As such, the PEGASE program, which is funded by the French government under Article 51, was developed to ensure adequate medical follow-up - both somatic and psychiatric - for children taken into care by child protective services (CPS). Children in the PEGASE program are monitored with regular, standardized check-ups, with an initial standardized check-up when the child enters the care facility followed by 20 regular assessments at fixed ages up to the age of 7. Most of these assessments are reinforced in PEGASE by the systematic use of standardized scales to identify potential disorders and developmental delays, so that the necessary care can be implemented at an early stage. An evaluation of the program's effectiveness and efficiency is needed to inform public decision-making on the appropriateness of extending it to all children in care. As there is no control group in the PEGASE program, this requires the creation of a control cohort of children followed by CPS but not benefiting from the PEGASE program. This is the ESPER cohort (Prospective cohort study of protected children), which will enable us to carry out a comparative evaluation of the PEGASE program, as well as to provide information on the health of children taken into care by the CPS at the time of their placement, and on its evolution over time, data which are rare in France. The primary objective is to evaluate the effectiveness of the PEGASE program on the evolution of the mental health of children followed by the CPS after 2 years of follow-up. The secondary objectives are: - To evaluate the effectiveness of the PEGASE program on the evolution of children followed by the CPS after 1 and 2 years of follow-up, in terms of: mental health, physical health, development (communication, gross motor skills and fine motor skills), care pathway, and school integration, - To evaluate the cost-effectiveness of the PEGASE program after 2 years of follow-up, and its budgetary impact in the case of generalization, - To describe the health of children when they are put into care. An ancillary study is also planned to compare the health of children followed by CPS to the health of children in the general population. This is a comparative study with an external control group and propensity score matching, calculated from a multivariate logistic regression model that will include a priori: corrected age at inclusion, gender, gestational age, ASQ-SE and ASQ-3 scores at inclusion, reason for placement, current protective measure, and social situation of both parents. The PEGASE program is already the subject of a separate protocol describing recruitment procedures and follow-up of children benefiting from the program. The population included in the ESPER study are children taken into care by CPS in 8 volunteer departments not participating in the PEGASE program. They must be aged less than 42 months (i.e. 3 and a half years), arriving for the first time in a participating center, and the holders of parental authority must not object to participation in the study. The children included the ESPER cohort will be followed as usual by the participating center during the two years of follow-up. Additional data collection by questionnaire will be added to the usual care at inclusion, and then at 1 and 2 years of follow-up either in person or by telephone by the study's local coordinators (if the child is no longer in the facility at the time of collection). At the inclusion visit, parents or legal guardians will be informed of the study, and their non-opposition will be sought. All socio-demographic, health and school data will be collected by the local coordinators. The ASQ-SE and ASQ-3 questionnaires will be completed, as well as antenatal and pre-placement health data. The data will then be entered into the eCRF by the local coordinators. At one year of follow-up, the local coordinators will collect health data (from the health records) and school data. If the child is no longer in the facility, data will be collected by telephone from the child's care takers, or from the parents (or holders of parental authority) if the child lives with them. The ASQ-SE and ASQ-3 questionnaires will be completed by the same person. The local coordinators will then enter the data into the tool. The 2-year follow-up visit will be identical to the 1-year visit. It is planned to include 400 children in the ESPER cohort. The inclusion period is 12 months, and the duration of each child's participation in the study is 24 months.
Phase
N/ASpan
209 weeksSponsor
Assistance Publique - Hôpitaux de ParisLille
Recruiting
Factors Sustaining Tobacco Abstinence in Cancer Patients Treated With Radio-chemotherapy or Radiotherapy
The TABAC STOP ORL POUMON study is a prospective, single-center observational study aiming to understand factors influencing long-term smoking cessation in patients treated for head and neck or lung cancer. Tobacco is a leading cause of death and disease, particularly in areas like Hauts-de-France with high smoking rates. Eligible patients, undergoing radiotherapy or chemoradiotherapy, are enrolled during the final week of treatment, completing questionnaires assessing nicotine dependence and alcohol use. Follow-ups are scheduled at 1, 6, and 12 months, through clinic visits or phone interviews. The primary endpoint is the proportion of patients who remain smoke-free at 6 months. Secondary endpoints include factors influencing smoking cessation, reasons for relapse, and changes in nicotine and alcohol dependence. The study will enroll 100 patients, expecting 81 evaluable cases, with data quality ensured through regular checks and source verification.
Phase
N/ASpan
197 weeksSponsor
Centre Oscar LambretLille
Recruiting
STRucturation of Transcript Analysis of Genes Involved in Hereditary Cancers
Systematic DNA/RNA analysis is never carried out using the current approach, due to a lack of resources. Strategies recommend pre-screening variants using in silico analysis, followed by RNA studies targeting variants of interest.
Phase
N/ASpan
83 weeksSponsor
University Hospital, RouenLille
Recruiting
Irritable Bowel Syndrome Regional Cohort
The strategy of this project is to develop a regional cohort of patients suffering from irritable bowel syndrome, in order to offer harmonised phenotyping, longitudinal follow-up and the study of clinical and biological factors associated with the development of the disease and its treatment. To achieve this, the study plans to prospectively collect a complete phenotyping of patients suffering from IBS and followed up in consultation in the participating centres (questioning, questionnaires, physiological explorations and results of complementary examinations), with follow-up of the course of the disease and which will be supplemented by stool samples for analyses of the microbiota and metabolites. The study aims to include all patients seen prospectively in the centres over a period of 2.5 years and to include as many stool samples as possible during follow-up visits. This should make it possible to include a total of 600 patients. This number will be sufficient to identify subgroups of patients with similar clinical or biological characteristics of reasonable size (at least 50 to 100 subjects each) and then compare their prognosis.
Phase
N/ASpan
261 weeksSponsor
University Hospital, RouenLille
Recruiting