Saint Pierre

Researchers are conducting a prospective, multicenter cohort study to follow children with idiopathic nephrotic syndrome INS, a rare kidney disease. The study aims to collect data on pediatric patients treated by pediatric nephrologists in France and its overseas territories to better understand the diseases characteristics and support future clinical trials. The study involves regularly recording medical, biological, psychological, and social data through routine clinical follow-ups, hospitalizations, and consultations. Additionally, annual telephone interviews will be conducted for patients in remission. Quality of life, treatment adherence, and treatment impact questionnaires will also be collected. A biobank is established to collect blood, urine, hair, and nail samples at the disease onset before immunosuppressive treatment begins. Participants will be followed from disease onset until age 18 or transfer to adult nephrology care. Data is collected via a secure website, medically validated and entered by clinical research staff. The main outcome is the number of cases included and their characteristics over two years. Participation involves routine care visits, interviews, and questionnaires, with continued monitoring planned through the study period ending in 2048.

Researchers are evaluating the efficacy and safety of amlitelimab, given as a subcutaneous injection, for treating moderate-to-severe atopic dermatitis AD in participants aged 12 years and older. This Phase 3, randomized, double-blind, placebo-controlled study includes participants who have not responded adequately to prior biologic or oral Janus kinase inhibitor JAKi therapies while using background topical corticosteroids TCS. Participants are randomly assigned to one of three groups receiving subcutaneous injections of either one of two doses of amlitelimab or a placebo, all alongside background TCS therapy. The treatment period lasts up to 36 weeks, followed by either a 16-week safety follow-up for those not entering the long-term safety study or no further treatment period for those entering the extension study. The entire study duration ranges up to 56 weeks for participants not entering the long-term safety study and up to 40 weeks for those who do. Participants will attend up to 13 visits during the study, or 12 visits if they join the long-term safety study. Assessments include evaluating skin condition using standardized scales such as the Validated Investigator Global Assessment for AD and the Eczema Area and Severity Index. Researchers will monitor safety, side effects, skin symptoms, quality of life, and various patient-reported outcomes. Long-term safety and response to treatment will also be observed for those who continue into the extension study.

This research aims to improve pregnancy success rates in women undergoing frozen embryo transfers FET after in vitro fertilization IVF. It evaluates whether placing a blank culture medium into the uterus a few days before the embryo transfer can enhance immune tolerance and support embryo implantation. The study compares this approach to a sham transfer procedure without the culture medium, focusing on women who have experienced previous embryo transfer failures. Participants are randomly assigned to one of two groups the experimental group receives a small amount of warmed embryo culture medium injected into the uterine cavity two to three days before the frozen embryo transfer, while the control group undergoes a sham transfer with an empty catheter during the same timeframe. The study is single-blind and involves multiple centers. During the trial, researchers will monitor pregnancy outcomes, including early pregnancy occurrence, biochemical and clinical pregnancy rates at various time points, early miscarriage rates, and live birth rates. They will also assess cost-effectiveness between the two care strategies. Participant involvement includes consent, membership in a health insurance plan, and follow-up evaluations up to and beyond the pregnancy period, with the primary outcome measured at 12 weeks of amenorrhea.

Anal canal cancers are becoming more common in France, especially among people living with HIV, who face a risk 30 times higher than the general population. This study focuses on people living with HIV aged 30 or older, including heterosexual men and women without vaginal cervical lesions, to evaluate anal HPV screening methods. The goal is to assess the agreement and acceptance of self-screening compared to screening performed by healthcare professionals as part of a strategy to detect anal cancer risk. Participants will be randomly assigned to one of two groups one group will perform anal self-swabbing first followed by a healthcare professional swabbing, and the other group will have the professional swabbing first followed by self-swabbing. Both methods involve collecting anal swabs to test for HPV, particularly the HPV-16 genotype known for its cancer risk. The study compares the results from the two sampling methods and gathers information on participant preference, satisfaction, and any side effects like discomfort or bleeding. During the study, participants will provide samples and answer questionnaires about their experience. Researchers will evaluate how well the self-sampling matches professional sampling and measure the prevalence of anal HPV infections. The study will also monitor any adverse events and assess overall acceptability of both methods. Participation includes follow-up within 7 days after sampling to gather results and feedback, with the entire process designed to improve anal cancer screening in this high-risk group.

This research aims to improve genetic counseling by classifying gene variants found in families with a history of hereditary cancers, especially breast and ovarian cancer. Initially focused on BRCA1 and BRCA2 genes, the study now includes multiple genes from a large French oncogenetics database, covering thousands of families and variants. The goal is to better understand which gene variants are linked to cancer risk and to refine how these variants are classified for clinical use. Participants include index cases carrying specific gene variants and their family members. The study collects saliva samples from relatives to test for the presence of these variants, particularly those classified as uncertain significance class 3, likely pathogenic class 4, or hypomorphic pathogenic class 5. Genetic analyses are performed by specialized laboratories, and data from multiple families is combined to assess how these variants co-segregate with cancer occurrence. Throughout the study, researchers analyze genetic data using statistical models to estimate the likelihood that certain variants cause cancer. They use anonymous results for overall variant classification and share findings with families when variants are found to be pathogenic. This helps guide genetic counseling, possible preventive measures, and clinical management. The study spans up to 15 years and continuously updates classification methods and clinical recommendations based on new data.

Immune thrombotic thrombocytopenic purpura iTTP is a serious condition caused by a severe deficiency of ADAMTS13, leading to the buildup of large von Willebrand factor multimers and formation of blood vessel clots. The current standard treatment combines daily plasma exchange PEX, immunosuppressive drugs, and caplacizumab, which has shown to reduce death, complications, and the number of PEX sessions. However, PEX is invasive, time-consuming, and linked to complications, so researchers are exploring treatments without PEX to ease patient care. This study aims to evaluate the safety and effectiveness of a regimen without PEX using plasma infusion, corticosteroidsrituximab, and caplacizumab. The study replaces daily PEX with daily plasma infusions at a dose of 15 mL per kilogram of body weight, using different types of plasma such as quarantine fresh frozen plasma or inactivated plasma. This PEX-free regimen is combined with immunosuppression using corticosteroids and rituximab alongside the anti-adhesive drug caplacizumab. This approach is being tested as a single experimental treatment group for adults diagnosed with iTTP. Participants will be monitored for 30 days after starting plasma therapy to evaluate treatment outcomes. Researchers will assess the proportion of participants who experience death, treatment failure, disease worsening, or low ADAMTS13 activity below 20%. The study includes clinical and laboratory evaluations to track safety and effectiveness. The overall goal is to determine if this PEX-free regimen can provide a feasible alternative treatment for iTTP with fewer complications.

Beach tennis is a fast-growing sport that started in Italy in the 1970s and has become especially popular in La Runion Island since 2000. Despite its growth, there is limited prospective research on injuries specific to beach tennis players. This study aims to better understand the risk and causes of injuries in beach tennis by following a group of players over one year to gather detailed injury data. Participants in this study are beach tennis players who regularly train at least once a week. After joining the study, players will report any injuries they experience monthly using an online questionnaire. The study will observe these players for one year to track injury risk, types of injuries, main risk factors, and overall injury patterns. During the one-year observation period, participants will provide monthly injury reports through online questionnaires. Researchers will analyze these reports to measure injury risk and understand the epidemiology of injuries in beach tennis. The study is sponsored by the Centre Hospitalier Universitaire de la Runion and aims to improve injury prevention and medical care for beach tennis players.

Bronchiectasis is a chronic lung disease involving permanent widening of parts of the airways, leading to mucus buildup, infections, and ongoing inflammation. Researchers are evaluating whether using the SIMEOX device at home, combined with remote physiotherapy, can improve quality of life and reduce lung flare-ups compared to enhanced standard care in patients with non-cystic fibrosis bronchiectasis. This study focuses on long-term effects over about two years. Participants will be randomly assigned to one of two groups one receiving standard care plus remote physiotherapy, and the other using the SIMEOX device daily at home along with remote physiotherapy and standard care. The SIMEOX device delivers short pulses of negative air pressure through a mouthpiece to help loosen and move mucus from the lungs. Remote physiotherapy sessions occur once a month for the first three months and then every three months thereafter. During the study, participants will be monitored for changes in quality of life using questionnaires at 6, 12, and 24 months, and the number of lung exacerbations over about 24 months will be recorded. Lung function tests spirometry will also be conducted periodically. Researchers will track treatment adherence, hospitalizations, and any adverse events. The total study duration per participant is around two years, with regular assessments to evaluate the impact of the SIMEOX device combined with physiotherapy.

Squamous cell carcinoma of the anus is a rare but increasingly common cancer, often linked to human papillomavirus HPV. For early-stage tumors, combined radiotherapy and chemotherapy with 5FU and mitomycin-C provide good outcomes, but advanced tumors have a poor prognosis with a high relapse rate. Researchers are studying a new approach combining induction chemotherapy with docetaxel, cisplatin, and 5FU mDCF followed by standard chemoradiotherapy to improve treatment results for locally advanced anal cancer T3-4 or N1. This is a randomized phase 3 trial comparing this new strategy to the current standard treatment. The study includes two groups one receives the usual chemoradiotherapy, which involves 33 radiotherapy sessions over 6.5 weeks combined with mitomycin-C and capecitabine chemotherapy taken on radiotherapy days. The other group starts with 4 cycles of mDCF chemotherapy given every two weeks before receiving the same chemoradiotherapy as the control group. Radiotherapy uses intensity-modulated external irradiation with a targeted boost to the tumor and involved lymph nodes. Participants will be followed after treatment with check-ups at 8 weeks, then every 4 months for two years, and every 6 months in the third year. Follow-up includes clinical exams and imaging scans CT and MRI. The main measure of success is disease-related event-free survival two years after treatment. Other outcomes include overall survival, colostomy-free survival, treatment side effects, tumor response, and quality of life. The total study duration for each participant may extend over several years including this follow-up period.

Researchers are studying the potential benefits of outpatient care for patients with acute uncomplicated appendicitis treated by laparoscopic appendectomy. This research aims to compare outpatient care with conventional hospital care to see if outpatient care is not worse in terms of overall morbidity and mortality within 30 days after surgery. The study is motivated by the need to optimize care pathways, reduce hospital stays, improve patient satisfaction, and lower healthcare costs, especially important during the COVID-19 pandemic. The trial compares two treatment groups one receiving ambulatory appendectomy where surgery is done in an outpatient surgery unit and patients are discharged the same day, and the other receiving conventional appendectomy where surgery occurs in the digestive surgery department and patients stay overnight for observation before discharge. The study evaluates outcomes up to 30 days after surgery, including hospital stay length, rehospitalization rates, complications, re-interventions, patient satisfaction, quality of life, and economic impacts. Participants will undergo assessments before and after surgery, with monitoring of clinical outcomes, patient satisfaction, and quality of life at 7 and 30 days post-operation. Researchers will also track safety, the rate of conversion from outpatient to conventional care, and costs associated with each care pathway. The total study participation includes follow-up for 30 days after surgery to assess the main and secondary outcomes.