Clermont-ferrand Cedex 3, France
French Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD)
Phase
N/ASpan
114 weeksSponsor
SanofiLe Puy-en-Velay
Recruiting
Impact of General Practice Follow-up on Emergency Hospitalization of Patients Admitted for Chest Pain
Phase
N/ASpan
42 weeksSponsor
Centre Hospitalier Emile RouxLe Puy-en-Velay
Recruiting
Rehabilitation Improved by Early Detection of Fisyulas Post (Pharyngo) -Total Laryngectomy by Cytokine Measurement on Drainage Fluid on the Second Post-Operative Day
Course of the study Patients will be recruited from the ENT departments of the Clermont Ferrand, Saint-Etienne, Lyon and Grenoble university hospitals, the Lyon (Centre Léon Bérard) and Paris (Institut Gustave Roussy) cancer centers, and the Le Puy En Velay and Valence hospitals, all of which are accredited for cervico-facial carcinology. A multidisciplinary consultation meeting will be required to validate the surgical procedure. Patients will be informed of the study by the investigating physician. After a period of reflection and a chance to answer any questions, the patient will be included in the study after consent has been obtained from an investigator. The main risk factors for the development of a fistula will be recorded pre- and intraoperatively. Surgical criteria will be common to all investigating teams. The most important of these will be the positioning of the LDPO collection drain opposite the pharyngeal closure site. The drain may or may not be aspirative, depending on local habits. The concomitant insertion of a phonatory prosthesis or a salivary bypass are not grounds for exclusion. Post-operative care must meet precise specifications. Drainage fluids will be collected from the drainage bottle on D2 post-op. To do this, the entire drainage bottle will be recovered, and a new bottle will be placed over the drain if the drain is retained. The liquid contained in the drainage bottle is then sterile-separated into different samples directly in the patient's hospital ward: - Immunological sampling. A BD Falcon™ Conical Tubes 50 mL will be sent to the immunology laboratory associated with the investigating center (Clermont-Ferrand University Hospital Immunology Laboratory for the Clermont-Fd and Le Puy en Velay sites, Lyon University Hospital Immunology Laboratory for the Grenoble, Lyon, Valence and Lyon anti-cancer center, the immunology laboratory of the Assistance Publique Hopitaux de Paris for the Gustave Roussy Institute and the immunology laboratory for the Saint-Etienne center). The sample is then centrifuged at 3,000 rpm for 10 minutes at 4°C.a "high-risk" group for CPE. - Bacteriological sampling. This sample will be sent rapidly to the bacteriology laboratory of the investigating center for standard cyto-bacteriological analysis. For an IL 10 level on D2 post-op of less than 72pg/mL (so-called low-risk fistula group defined from the DEFILAC pilot study), two groups of patients will be constituted: Low-risk fistula group: OPT performed on D3 or D4 (before randomization and after IL-10 results). If TPO classified according to van la Parra ≤1, patients will be randomized into 2 groups: - "EARLY" group: Resumption of feeding on postoperative day 3 or 4 with a liquid or mixed diet. - "TARDIF" group: return to a mixed diet from day 7 post-op. Randomization will be centralized, computerized with random block sizes, stratified by center and patient age. If the TOP shows images classified according to van la Parra>1, patients will join the so-called high-risk CPE exploratory arm. If IL10 levels on D2 post-op exceed 72 pg/mL (high-risk group for post-op fistula), these patients will form a third, exploratory group, whose management will be left to the investigator's choice, with 3 possibilities (no change in investigators' habits): repeat surgery to clean the surgical site and repair the pharyngeal sutures, broad-spectrum antibiotic therapy while awaiting the bacteriological results of the cytobacteriological examination of the drainage fluid on postoperative day 2, without repeat surgery, monitoring and no change in the investigator's routine. Postoperative complications will then be noted and classified according to the Clavien-Dindo classification over a period of 30 postoperative days. The appearance of a salivary fistula at the tracheostoma will be objectified by the appearance of saliva in the tracheostoma. The appearance of a fistula at the cervical level will be sought either by imaging methods in the event of a cervical complication (infection, hemorrhage) if no surgical revision is decided and surgically by loss of sealing confirmed surgically if a revision is necessary. The appearance of a subsequent fistula will be noted. The patient will have a final consultation 30 days after surgery if he or she is no longer hospitalized. The quality of life of the patients will be assessed throughout the study by completing an anxiety questionnaire and a depression questionnaire. This assessment will be done before surgery, on D5, D15 and D30 of surgery. Before surgery and at D5, these questionnaires will be completed during hospitalization. At D15 and D30, the questionnaires will be completed during hospitalization if the patient is still hospitalized or by mail if the patient has been discharged from the surgical department having performed the pharyngolaryngectomy procedure. The date of the start of chemoradiotherapy will then be noted and the time between surgery and the start of this treatment will be noted.
Phase
N/ASpan
172 weeksSponsor
University Hospital, Clermont-FerrandLe Puy-en-Velay
Recruiting
Telemonitoring Platform "CUREETY TECHCARE" vs Standard of Care for mTBNC Patients Initiating a First-line Treatment
Phase
N/ASpan
162 weeksSponsor
UNICANCERLe Puy-en-Velay
Recruiting
Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair
This study is a non-interventional, multicenter and post market clinical follow-up in adult women with apical prolapse under normal conditions of use (after a sacrocolpopexy with Restorelle mesh for apical prolapse repair as part of routine care). The patient will be followed for 1 year (or less) by the investigator as per local usual practice. At the same time, the patient will be followed via PRO (Patient Reported Outcomes) over a period of 5 to 8 years.
Phase
N/ASpan
424 weeksSponsor
Coloplast A/SLe Puy-en-Velay
Recruiting
Effectiveness of the ARTH-e Application on Adherence to Physical Exercises in Patients Suffering From KOA: RCT
Knee osteoarthritis is the most common joint disease affecting the joint itself as well as the peri-articular structures in a global and progressive manner. It can affect all the joints of the body, with a predominance for those which undergo strong mechanical constraints such as the rachis, the hip or the knee. It is a chronic pathology correlated with age, since nearly one adult in two is affected by osteoarthritis. Today, connected objects have taken a predominant place in the daily life of the majority of the population, including seniors. It is an object of communication and socialization as well as a major information tool. E-health applications are more and more numerous in the stores and are a tool for assistance, information and support already used in many fields. In the context of therapeutic education, it is a motivational tool that can accompany patients by adapting to their needs and progress compared to traditional self-exercise methods. Studies of the obstacles and levers for the use of smartphone applications in chronic pathologies such as low back pain support the development of this tool.
Phase
N/ASpan
90 weeksSponsor
University Hospital, Clermont-FerrandLe Puy-en-Velay
Recruiting
Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy
Phase
N/ASpan
261 weeksSponsor
University Hospital, Clermont-FerrandLe Puy-en-Velay
Recruiting
A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma
Phase
3Span
298 weeksSponsor
Regeneron PharmaceuticalsLe Puy-en-Velay
Recruiting
A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer
Despite substantial progress made in the first- and second line mCRC settings, there are still unmet clinical needs for patients harboring BRAFV600E mutations, especially those with microsatellite stability (MSS) / proficient mismatch repair (pMMR) tumor. The overall survival and access to different treatment in the real-life setting are unknown. Moreover, patient prognosis remains poor and therapeutic resistance to combinations with BRAF inhibitors, is at present, nearly universal. Therefore, it seems essential to prospectively collect clinical and biological data about this rare mCRC subtype. These data will allow us to improve knowledge and to identify clinical and biological factors that could drive therapeutic decisions, predict resistance to treatments, and that are prognostic for survival. In this context, we designed this large, prospective, cohort study to collect clinical data and biological samples to be used for research but also to gather real-world clinical data concerning the treatments and the survival outcomes in patients with BRAFV600E mCRC. This collection of clinical and biological data (tumor tissue and blood samples) will allow us to identify predictive and prognostic biomarkers with several research work packages planned: i. To evaluate the circulating tumor DNA (ctDNA) during the metastatic first-, second-, and third-line treatment to: - Evaluate its positive and negative predictive value. - Identify molecular alterations preceding and explaining clinical resistance during BRAF/EGFR inhibition therapy and immunotherapy. ii. To evaluate BRAFV600E mCRC immune environment both at the tumor and blood level (immunomonitoring). iii. To study specific the dMMR/MSI BRAFV600E subgroup. Furthermore, the data collected will describe the therapeutic management of BRAFV600E mCRC patients in the routine-practice setting which will bring very useful data. The results of the COBRAF study could lay the groundwork to better understand BRAFV600E mCRC and to identify prognostic and predictive biomarkers helping the development of new therapeutic approaches in this population.
Phase
N/ASpan
262 weeksSponsor
UNICANCERLe Puy-en-Velay
Recruiting
Optimization of the Care Pathway for Patients With Chronic Pain: Assessing the Value of Integrating Sleep Specialists
Phase
N/ASpan
178 weeksSponsor
Centre Hospitalier Emile RouxLe Puy-en-Velay
Recruiting