Fort De France

Transthyretin amyloidosis ATTR is a condition where the transthyretin protein breaks down and forms amyloid plaques that build up in organs, causing damage. There are two types wild-type ATTR, which occurs with aging, and variant ATTR caused by inherited defective TTR genes. This study focuses on adults who have inherited a pathogenic TTR gene variant but do not yet show symptoms, aiming to see if early treatment can prevent or delay disease development. The trial is a Phase 3, randomized, double-blind, placebo-controlled study evaluating prevention of ATTR cardiomyopathy and polyneuropathy. Participants will be randomly assigned to receive either acoramidis, a drug designed to stabilize the TTR protein and prevent amyloid formation, or a matching placebo. The study drug is taken orally twice daily at a dose equivalent to 800 mg acoramidis HCl BID. Participants will be adults aged 18 to 75 years whose age falls within 10 years younger or older than their predicted age of disease onset based on family history or actuarial tables. The trial will last approximately 7 years from randomization or until study end. During the study, participants will be monitored regularly with evaluations to detect the development of ATTR cardiomyopathy or polyneuropathy. Researchers will assess time to disease onset using centrally adjudicated criteria. Safety and adherence will be tracked throughout the trial. This long-term study will help determine if early treatment with acoramidis can delay or prevent symptoms in asymptomatic carriers of pathogenic TTR variants.

Researchers are conducting a Phase III international trial to study the effects and safety of androgen deprivation therapy ADT with or without darolutamide in men newly diagnosed with metastatic prostate cancer who have vulnerable functional abilities. This study specifically includes patients who have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The goal is to evaluate how these treatments impact disease progression and patient health over time. Participants will be randomly assigned to one of two groups one receiving ADT plus darolutamide 600 mg taken orally twice daily, and the other receiving ADT plus a placebo taken with the same schedule. Treatment will continue until imaging shows disease progression or until the patient or doctor decides to stop for reasons such as side effects or other health issues. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, further treatments, and any ongoing or new side effects. During the study, participants will undergo regular assessments including imaging scans to check for cancer progression, blood tests, evaluations of urinary symptoms, and quality of life questionnaires. Researchers will track outcomes like progression-free survival, overall survival, symptom changes, and adverse events. Monitoring visits will occur periodically both during treatment and follow-up to gather comprehensive data on health status and treatment effects.

Researchers are investigating autoinflammatory diseases AID, which involve recurring inflammatory episodes without infection, cancer, or adaptive immune system problems. This study focuses on both monogenic hereditary periodic syndromes and polygenic or multifactorial AID, including rare conditions like Behets disease, Still disease, Schnitzlers disease, PFAPA syndrome, chronic recurrent multifocal osteomyelitis, non-infectious uveitis and scleritis, among others. The goal is to gather detailed data to improve understanding and management of these rare diseases through an international collaboration. The study uses the AIDA registry, a secure online platform for collecting demographic, genetic, clinical, laboratory, radiologic, and therapeutic information. Data are gathered retrospectively and prospectively during routine clinical visits scheduled every 3-6 months. Eleven registries focus on different AID conditions, enabling comprehensive data collection to identify clinical patterns, treatment impacts, and long-term outcomes over a period of at least 10 years. Participants provide information during their usual care visits, allowing researchers to track changes in disease activity, organ involvement, inflammatory markers, visual function, pain levels, fatigue, fertility, and socioeconomic factors. The study monitors these outcomes over multiple timepoints up to 120 months. Data privacy is ensured by pseudonymizing patient information. This registry supports multiple clinical studies and aims to enhance knowledge, awareness, and future research on autoinflammatory diseases worldwide.

Prostate cancer is the most common cancer among men in industrialized countries like France and is the third leading cause of cancer-related death in men. This research investigates the possible link between exposure to chlordecone, an insecticide used in the French West Indies until 1993, and prostate cancer in Martinique. The study also considers other environmental factors and genetic variants that may influence prostate cancer risk, especially among men of Afro-Caribbean origin, who have higher incidence rates. The study is observational and includes three groups of adult men under 75 years old residing in Martinique for at least six months those newly diagnosed with prostate cancer, those with a negative prostate biopsy after elevated PSA levels, and those with PSA levels below 2.5 ngml. Participants will provide a blood sample for chlordecone measurement and complete a questionnaire during a single inclusion visit over a 36-month recruitment period. Participants will be assessed for chlordecone and other pollutant exposure, serum Prostate-Specific Antigen levels, and prostate cancer aggressiveness through medical records and imaging data. Additional analyses include studying chlordecone distribution in blood and tissues, molecular signatures in tumor tissues, and genotyping genetic variants. The research team will analyze the collected data after the recruitment to explore the association between chlordecone exposure and prostate cancer risk.

Researchers are studying suicide and mental health risk factors in four French overseas territoriesFrench Polynesia, La Reunion, French Guiana, and Martiniqueby comparing them to a site in mainland France Amiens. The study aims to identify common or unique suicide risk factors in these diverse populations using a combined quantitative and qualitative approach including psychological autopsy interviews. The study involves collecting data from relatives of people who died by suicide through two semi-structured storytelling interviews. These interviews use various questionnaires and evaluation tools such as the Structured Clinical Interview for Diagnostic SCID, Life Trajectory questionnaire, anthropological evaluation grid, and others to explore mental disorders, life events, socio-cultural aspects, and emotional states. A maximum of 30 cases per site will be included over a 23-month recruitment period. Participants will be interviewed twice once between 2 and 11 months after the suicide, and again one month later for follow-up. This follow-up helps provide support to the bereaved and assess the impact of the interviews. Researchers will analyze risk factors, mental disorders, childhood or lifetime violence, adversity scores, and social and cultural elements linked to suicide risk. The total study duration is 24 months, with each participant involved for about one month after initial inclusion.

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.

This research aims to describe HIV prevention practices in over 23 HIV sites across France, including overseas locations. It focuses on various aspects such as HIV screening, sexually transmitted infections STI screening, hepatitis screening, and the use of post-exposure prophylaxis PEP and pre-exposure prophylaxis PrEP. The study is observational and seeks to collect detailed information about HIV prevention measures in these diverse settings. Participants in this cohort study are observed based on their attendance for HIV prevention services including HIV, hepatitis, and STI screenings, as well as their use of PEP or PrEP. The study does not involve investigational treatments but follows participants over time to gather data on these prevention practices according to French national guidelines. During the study, researchers will track the number of people enrolled for HIV prevention over about one year, as well as proportions using PrEP and PEP and undergoing hepatitis and STI screenings. They will also monitor the incidence of sexually transmitted infections and hepatitis. Participants will provide informed consent and their progress will be observed without altering their usual care or treatment.

Dengue fever is a mosquito-borne virus that causes significant health problems in tropical and subtropical regions. There is currently no antiviral treatment, and controlling mosquitoes has limitations. The tetravalent Dengvaxia4 vaccine, authorized in Europe in 2018, is used to prevent dengue in people aged 9 to 45 who have had prior dengue infection and live in areas with high infection rates. This study focuses on estimating dengue virus seroprevalence among 9- to 17-year-olds in Martinique and Guadeloupe, where previous data was limited to adults. Researchers will collect blood samples from children aged 9 to 17 who visit participating hospital departments to measure dengue and Zika virus antibodies. The study also includes a survey for parents or guardians to assess their willingness to accept the dengue vaccine and understand factors influencing vaccine hesitancy. This combined approach aims to support optimal vaccine introduction and better healthcare planning in these regions. Participants will provide a blood sample during hospital visits and complete questionnaires. Researchers will test for dengue and Zika antibodies to determine infection history and vaccine eligibility. They will track dengue seroprevalence, incidence of primary dengue infection, changes in infection risk over time, and vaccine acceptability. The study results will help guide dengue vaccination strategies and improve management of future dengue outbreaks. Participation duration averages about one year for outcome measurements and surveys.

Snakebites from Bothrops species are a significant health concern in French Guiana and Martinique, with envenomation causing severe local and systemic effects. This research aims to explore the role of plasma Willebrand factor activity and endothelial activation in patients bitten by Bothrops snakes in these regions. The study investigates how venom from different Bothrops species affects blood clotting and inflammation, potentially explaining distinct clinical outcomes like bleeding or thrombosis. Understanding these mechanisms could lead to more personalized treatment approaches for snakebite victims. Participants include patients with confirmed Bothrops snakebites from French Guiana and Martinique, divided into two groups of 15 each. Blood samples will be collected for research analysis alongside routine care, focusing on Willebrand factor activity before and after anti-venom treatment. The study does not involve new treatments but monitors biological markers related to coagulation and endothelial function to understand venom effects better. During the study, patients will have additional blood drawn at hospital admission and on days 1 and 8 to measure plasma Willebrand factor activity. Researchers will assess coagulation status and related biological changes while recording clinical signs of envenomation. The study is observational, with no experimental interventions, and participants are followed up during their hospital stay to gather data on venom effects and recovery. Total participation duration varies depending on clinical course but includes key blood sampling points within the first week.

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.