Saint Pierre

Researchers are creating a national, prospective cohort to study children with idiopathic nephrotic syndrome (INS), a rare kidney disease. The goal is to collect detailed data on patients treated in pediatric nephrology centers across France, Reunion Island, Mayotte, and eventually other French overseas territories. This structured follow-up aims to better understand the disease's characteristics and provide a foundation for future clinical trials. The study involves enrolling pediatric patients diagnosed with INS and systematically collecting clinical, biological, psychological, and social data. Biological samples such as blood, urine, hair, and nails will be gathered at disease onset before immunosuppressive treatment begins. Data will be recorded through medical records from hospital visits and consultations, supplemented by annual telephone interviews for patients without active disease. Quality of life, treatment adherence, and aesthetic impact questionnaires will also be collected and integrated into a secure database. Participants will be followed over at least two years, with data collected regularly by clinical research staff. This includes medical validation of clinical information, annual telephone follow-ups, and questionnaire assessments. The study's primary outcome is the number and characteristics of included cases over two years. This ongoing monitoring will support future nested studies and improve understanding of pediatric INS outcomes and management.

Researchers are evaluating the effectiveness and safety of subcutaneous amlitelimab compared with placebo in people aged 12 years and older who have moderate-to-severe atopic dermatitis (AD) and have not responded well to prior biologic or oral Janus kinase inhibitor (JAKi) therapies. This Phase 3, multinational, randomized, double-blind, placebo-controlled study includes participants who are also using background topical corticosteroids (TCS). The goal is to see how well amlitelimab works in improving AD symptoms in this group. Participants will be randomly assigned to one of three groups receiving either amlitelimab or placebo by subcutaneous injection while continuing their topical treatments, which may include corticosteroids, tacrolimus, or pimecrolimus. The total treatment period lasts up to 36 weeks during a double-blind phase. After the treatment phase, participants can choose to join a long-term safety study. The full study duration is up to 56 weeks for those not entering the safety study and up to 40 weeks for those who do, including screening, treatment, and safety follow-up periods. During the study, participants will attend up to 13 visits (or 12 for those continuing into the long-term safety study) for assessments including the Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD), Eczema Area and Severity Index (EASI), and symptom scoring. Safety monitoring and follow-up visits will track progress, side effects, and treatment response. The primary outcomes focus on improvements in skin clearing and reduction of AD severity at Week 36.

Researchers are investigating whether transferring a "blank" culture medium into the uterus a few days before a frozen embryo transfer can improve embryo implantation and pregnancy success in women undergoing in vitro fertilization (IVF). This study focuses on patients who have experienced pregnancy failure after a previous fresh or frozen embryo transfer. The goal is to enhance immune tolerance in the uterus to improve clinical pregnancy rates without increasing multiple pregnancies. The trial compares two procedures: one group receives a "blank" culture medium transfer, where a small amount of embryo culture medium is inserted into the uterine cavity two to three days before the frozen embryo transfer. The other group undergoes a sham transfer using an empty catheter at the same timing. The study is randomized, single-blind, and conducted across multiple centers. Participants' involvement includes undergoing these transfer procedures and subsequent frozen embryo transfers. Researchers will monitor pregnancy outcomes, specifically the clinically progressive pregnancy rate at 12 weeks of amenorrhea. Participants must provide informed consent and be covered by health insurance. The study also monitors for any pregnancy failures following the embryo transfers.

Anal canal cancers are becoming more common in France, with about 2,000 new cases each year. People living with HIV have a 30 times higher risk of developing anal cancer compared to the general population. This risk is especially high in people over 30, including heterosexual men and women living with HIV. However, routine proctological exams and HPV screening are not systematically offered to these groups. This study focuses on screening for anal HPV, particularly the HPV-16 type linked to anal cancer, in people over 30 living with HIV, including those not currently offered screening. The study compares two methods of HPV screening: self-sampling and sampling performed by healthcare professionals using anal swabs. Participants will perform anal swabbing themselves and also have it done by a healthcare provider. This approach aims to assess how well the results from self-sampling match those from professional sampling and how acceptable self-sampling is to participants. The study is conducted at the University Hospital of Reunion Island. Participants will be involved in anal swabbing and will complete a questionnaire. Researchers will evaluate the agreement between HPV-16 test results from self-collected and professionally collected samples within 7 days. The study also monitors participants' ability to perform self-sampling and their response to the screening process. The total participation duration and follow-up details are based on the short-term evaluation of HPV genotype concordance.

Researchers are studying gene variants of uncertain significance (VUS) found in genes linked to hereditary breast, ovarian, and other cancers. The goal is to better classify these VUS using data from a large French genetic database to improve genetic counseling and help guide clinical decisions, including preventive surgeries. The study originally focused on BRCA1 and BRCA2 genes but now includes multiple cancer-related genes identified through ongoing genetic testing in French families. Participants include index cases who carry specific VUS classified as uncertain or likely causal, along with their selected family members. Saliva samples are collected from these relatives to test for the presence of the variants. The study uses co-segregation analysis, which examines how the variant tracks with disease within families, applying a Bayesian model alongside other genetic and clinical data to estimate the likelihood that a variant causes cancer. Participants provide informed consent and saliva samples for genetic testing. Researchers compile data from multiple families to strengthen the classification of variants. The primary outcome is to perform co-segregation analysis over a period of up to 15 years. This long-term study aims to refine the clinical relevance of genetic variants to support personalized cancer risk assessment and counseling for affected families.

Immune thrombotic thrombocytopenic purpura (iTTP) is caused by a severe deficiency of ADAMTS13 due to autoantibodies, leading to harmful blood clots in small vessels. The current standard treatment combines daily plasma exchange (PEX), immunosuppressive drugs, and caplacizumab, which has helped reduce death and complications. However, PEX is invasive, time-consuming, and linked to complications, so researchers want to explore a treatment without PEX to reduce patient burden. This study evaluates a PEX-free regimen that uses daily plasma infusions (15 mL/kg/day) instead of plasma exchange, combined with corticosteroids or rituximab and caplacizumab. The plasma infusions involve quarantined or viral-inactivated plasma products. This approach aims to provide effective treatment with fewer risks and less complexity. The study is a multicenter, single-arm, non-inferiority trial assessing this combined therapy's safety and effectiveness. Participants will be closely monitored for 30 days after plasma therapy, tracking outcomes like death, treatment failure, disease worsening, or low ADAMTS13 activity. Researchers will assess how well the PEX-free regimen works compared to historical data. The study includes thorough clinical and laboratory evaluations to ensure patient safety and gather important treatment response information.

Beach tennis is a fast-growing sport that started in Italy in the 1970s and has become especially popular on La Réunion island since 2000. Despite its growth, there is limited research on injuries specific to beach tennis, mostly from cross-sectional studies that have some limitations. This research aims to better understand the risk and causes of injuries in beach tennis through a one-year national prospective cohort study. The study will follow beach tennis players over one year to determine their risk of injury. Participants include men and women who regularly train in beach tennis at least once a week. The study does not involve specific treatments or interventions but focuses on observing and collecting data about injuries as they occur during the year. Participants will be monitored throughout the year, with researchers assessing injury occurrences and collecting relevant information. The main outcome measured is the risk of injury during this period. This approach will help provide clearer insights into injury patterns and factors in beach tennis players to improve prevention and medical care.

Bronchiectasis is a chronic lung condition where parts of the bronchial tubes become permanently widened, leading to mucus buildup, infections, and ongoing inflammation. Managing this disease often includes respiratory physiotherapy to help clear mucus. However, accessing this therapy regularly can be difficult due to time, location, and availability of trained professionals. Researchers are evaluating the long-term use of the SIMEOX device, which uses brief air pressure pulses to help loosen and move mucus, combined with remote physiotherapy, to improve the quality of life and reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis. The study compares two groups: one using the SIMEOX device daily at home along with remote physiotherapy sessions, and a control group receiving enhanced standard care plus remote physiotherapy. The remote physiotherapy is delivered monthly for the first three months and then every three months afterward. The study lasts on average 24 months, allowing assessment of the device's effects over the mid and long term. Participants will be monitored through quality of life questionnaires and tracking of pulmonary exacerbations during the study. Evaluations include respiratory assessments and ensuring participants can use the device and follow procedures. The main outcomes measured are changes in respiratory quality of life after six months and the annual rate of lung exacerbations over the full study period. Safety and treatment adherence will also be continuously reviewed throughout participation.

Researchers are investigating treatments for locally advanced anal squamous cell carcinoma, a rare but increasing cancer often linked to human papillomavirus (HPV). The study compares standard chemoradiotherapy, which combines radiation and chemotherapy with 5FU and mitomycin-C, to a new approach adding induction chemotherapy (modified DCF protocol) before the standard chemoradiotherapy. This randomized phase 3 trial aims to improve disease-related event-free survival and other outcomes such as overall survival, colostomy-free survival, treatment tolerability, response rate, and quality of life in patients with T3-T4 or N1 stage anal cancer without metastasis. Participants in the experimental group receive four cycles of induction chemotherapy (docetaxel, cisplatin, and 5-FU given every two weeks), followed by standard chemoradiotherapy consisting of 33 sessions of radiation over 6.5 weeks combined with mitomycin during weeks 1 and 5 and capecitabine taken on radiation days. The control group receives only the standard chemoradiotherapy. Radiation is delivered using intensity-modulated external irradiation (IMRT-SIB) targeting the pelvis and tumor area with specified doses. During the study, patients undergo follow-up visits starting 8 weeks after treatment, then every 4 months for two years, and every 6 months for a final year. Follow-up includes clinical exams and imaging tests such as CT and MRI. The study measures disease-related event-free survival at 2 years after treatment completion as the primary outcome. Participants must be adults aged 18 or older with measurable tumors on MRI and able to receive chemotherapy and radiotherapy, with additional health criteria assessed before enrollment.

Researchers are evaluating the safety and quality of outpatient care compared to conventional hospital care for patients with acute uncomplicated appendicitis who undergo laparoscopic appendectomy. The study focuses on whether same-day discharge is as safe and effective as staying overnight in the hospital. This approach aims to improve patient satisfaction, reduce hospital stays, lower healthcare costs, and limit exposure risks during situations like the COVID-19 pandemic. The trial compares two treatments: ambulatory appendectomy, where the surgery is done in an outpatient unit and patients leave the hospital the same day, and conventional appendectomy, where patients stay overnight under observation after surgery in a digestive surgery department. Patients included are those with confirmed uncomplicated appendicitis and meet specific health and monitoring criteria, such as having a relative available for monitoring after discharge and living close to a hospital. Participants will be followed for 30 days after surgery to monitor overall safety and recovery. Researchers will assess complications, health status, and any morbi-mortality events during this period. The study includes careful screening before surgery, ongoing safety monitoring, and uses imaging and laboratory tests to confirm eligibility and health status. The total participation period covers the surgery day and 30 days of postoperative follow-up.