Saint Marcel Campes

Researchers are studying three rare types of skin cancer Merkel cell carcinoma, advanced basal cell carcinoma that needs systemic treatment, and cutaneous adnexal carcinomas. These cancers have limited information available about their natural course, prognosis, treatment, and outcomes. The CARADERM project is a national effort in France to collect detailed information about these rare tumors to better understand their characteristics and improve patient care. This study will enroll patients from multiple French centers who have one of these rare skin cancers. It will create a centralized database to track clinical and epidemiological details, including patient factors, cancer stage, lymph node involvement, treatment types such as medical, surgical, and radiotherapy interventions, and responses to these treatments. The database will also record dates of recurrence, death, and latest follow-up. Participants will have their clinical information monitored over time, with data collected on their cancer progression and treatment results. The main outcome measured is the incidence and natural history of these rare skin cancers over a period of 10 years. This long-term follow-up will help researchers identify new prognostic factors and assess how different treatments affect patient outcomes.

Acute hypoxemic respiratory failure often requires endotracheal intubation and invasive mechanical ventilation in about 30-40% of cases due to severe low oxygen levels or signs of respiratory distress. The main goals of invasive ventilation are to reduce breathing effort and improve oxygen supply. However, this approach can cause complications such as circulatory problems, muscle weakness, lung injury from the ventilator, and infections. This study aims to compare two intubation strategies to find the best balance between early intubation risks and ventilator-related harms in patients with this condition. The trial compares a liberal intubation strategy, where intubation is recommended if oxygen levels measured by SpO2FiO2 fall below 110 for more than 5 minutes or if restrictive criteria occur, with a restrictive strategy that recommends intubation only when more severe signs such as respiratory distress, very low oxygen levels below 88, neurological issues, or unstable blood circulation persist for over 5 minutes. Participants are randomly assigned to one of these two approaches to evaluate which better manages treatment risks and benefits. Participants will be monitored up to 28 days after enrollment to assess outcomes such as the duration of organ support considering survival, rates and timing of intubation, severity of organ failure, care duration, and adverse events related to the procedures and ventilation. Additional assessments include quality of life at day 90 and lung volume measurements by electrical impedance tomography at 1, 24, and 48 hours. Continuous monitoring will capture immediate and long-term effects of the intubation strategy under study.

Researchers are studying auto-immune hepatitis, focusing on patients who do not show typical autoantibodies seronegative. The study aims to understand how common this seronegative form is and whether it relates to how severe the disease is. Severity will be assessed by treatment resistance or dependence on steroids and by severe disease signs like cirrhosis or sudden liver failure. If seronegative cases are common, the study will look for other rare autoantibodies linked to the disease. Participants include those with acute or chronic auto-immune hepatitis from specific hospitals or disease centers in Guadeloupe and Saint-Antoine. Blood samples will be collected to create a serological library, helping researchers find rare autoantibodies that may serve as markers for disease prognosis. This observational study involves analyzing past patient data and following new patients over time. Participants will provide blood samples at inclusion and be monitored to assess disease severity at six and twelve months. The main outcome is a histological review of seronegative cases at the start. Secondary outcomes include severity evaluations and building a serotheque to identify other autoantibodies. The study ensures informed consent and follows patients receiving immunosuppressive treatment under usual care settings.

Researchers are collecting biological samples to improve diagnosis and treatment of rare neuroimmune disorders affecting the central and peripheral nervous system. These disorders include Paraneoplastic Neurological Syndromes PNS and Autoimmune Encephalitis AE, which involve immune system activity. The study aims to support faster and more accurate diagnosis, benefiting patients with these conditions by enhancing future treatment approaches. Participants diagnosed with PNS or AE will have biological samples collected once, including blood and possibly cerebrospinal fluid if available. Blood samples will be used to obtain serum, buffy coat, plasma, and peripheral blood mononuclear cells. If cerebrospinal fluid is drawn for diagnosis, any remaining sample will be stored. This collection will occur during a single visit, and samples will be stored for up to 10 years. During the study, participants will provide consent and undergo sample collection only once. Researchers will monitor the blood samples and cerebrospinal fluid biocollection over 10 years. The study emphasizes scientific collaboration and ongoing research to improve understanding and treatment of these neurological disorders. Participation duration focuses on the collection and long-term storage of biological samples.

Researchers are evaluating the efficacy, safety, tolerability, and pharmacokinetics of VX-147 in adults and children aged 10 to 65 who have APOL1-mediated proteinuric kidney disease. This study includes participants with specific APOL1 genotypes and aims to understand how VX-147 affects kidney function over time in this population. Participants are randomly assigned to receive different doses of VX-147 or a matching placebo. Those in the initial phase Part A will receive their assigned treatment for at least 96 weeks. Participants who complete Part A will then receive VX-147 for an additional 96 weeks in Part B. The study uses tablets taken orally and includes a placebo control group. During the trial, participants will be monitored regularly for changes in urine protein to creatinine ratio and kidney function measured by estimated glomerular filtration rate eGFR. Safety and tolerability are assessed through tracking adverse events throughout the study, which may last around four years after the last participant enrolls. Blood levels of VX-147 will also be measured, and pediatric participants will be asked about their satisfaction with the tablet form.

Researchers are conducting a French non-interventional longitudinal multicenter cohort study to evaluate the added value of olaparib for treating patients with metastatic castration-resistant prostate cancer mCRPC in real-world settings. The study aims to assess treatment sequencing, effectiveness, safety, and BRCA testing patterns, helping to inform future clinical practice. This observational study is sponsored by AstraZeneca. The study observes adult male patients who have started olaparib treatment within at least the last two months or who participated in a funded early access program. There are no assigned treatment groups or interventions beyond olaparib use as decided by their physician. Data collection continues up to 32 months to capture treatment patterns and patient characteristics. Participants data on treatment duration, disease progression, therapy sequences, symptomatic skeletal events, and BRCA testing timing will be collected and analyzed up to 24 months from olaparib initiation. Socio-demographic and clinical characteristics of patients and physicians will be gathered at the end of enrollment. The study monitors reasons for dose changes, interruptions, and treatment cessation, ensuring comprehensive real-world evidence about olaparib in mCRPC patients.

This trial is focused on patients with intermediate-risk differentiated thyroid cancer. It aims to compare two approaches for administering radioiodine treatment a systematic administration versus a decision guided by post-operative evaluations including serum thyroglobulin levels and diagnostic radioiodine scintigraphy. The study is a Phase III, multicenter trial sponsored by Centre Francois Baclesse, designed to evaluate treatment strategies for this specific thyroid cancer subgroup. Participants will be assigned to one of two groups. The first group receives a systematic radioiodine treatment with doses of either 3.7 GBq or 1.1 GBq of I131, determined by the investigator after recombinant human TSH stimulation. The second groups treatment decision is personalized based on post-operative assessments no treatment if certain thyroglobulin thresholds and scintigraphy are normal lower or higher doses if specific serum levels or metastases are detected, with hormone withdrawal used in some cases. Treatment is guided by these detailed clinical criteria. Throughout the trial, participants will be monitored for tumor response at 36 months after randomization, focusing on the rate of excellent tumoral response. Secondary measures include quality of life, salivary, nasal, and tear duct toxicities, management costs, and anxiety levels assessed at various times during and after treatment. Follow-up will continue annually for five years. Patients undergo evaluations such as serum tests and imaging to guide treatment decisions and monitor outcomes during the study period.