Fort De France

Transthyretin amyloidosis (ATTR) is a condition where the transthyretin (TTR) protein breaks down and forms amyloid plaques that build up in organs, causing damage. This can happen either as people age (wild-type ATTR) or due to inherited defective TTR genes (variant ATTR). When amyloid deposits affect the heart, it leads to transthyretin amyloid cardiomyopathy (ATTR-CM), and when it affects nerves, it causes transthyretin amyloid polyneuropathy (ATTR-PN). Researchers are evaluating acoramidis, a drug designed to stabilize the TTR protein to prevent or delay these conditions in adults who carry a pathogenic TTR gene variant but do not yet show symptoms. The study is a Phase 3, randomized, double-blind, placebo-controlled trial involving asymptomatic adults aged 18 to 75 years who carry a known pathogenic TTR variant. Participants receive either acoramidis or a placebo pill taken orally twice daily. Participants are selected based on their age being within 10 years younger or older than their predicted age of disease onset, which is estimated from family history or published data. The study aims to prevent or delay the development of ATTR-CM or ATTR-PN over approximately 7 years. Participants will be closely monitored throughout the study period for the time to development of ATTR, either cardiomyopathic or polyneuropathic forms, as determined by central adjudication. Assessments include genetic testing confirmation, cardiac magnetic resonance testing, and evaluation for any signs of disease progression. Safety and treatment adherence will also be monitored. The study may last up to 7 years or until it is declared over, with careful follow-up to detect any early signs of disease or treatment effects.

Researchers are conducting a Phase III, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of androgen deprivation therapy (ADT) with or without darolutamide in men with newly diagnosed metastatic prostate cancer who have vulnerable functional ability. These patients have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 participants who meet specific frailty and disease criteria. Participants will be randomly assigned to one of two groups: the experimental group will receive ADT plus darolutamide 600 mg taken orally twice daily, and the control group will receive ADT plus a placebo taken orally twice daily. Treatment will continue until there is evidence of disease progression on radiographic scans or if the patient or investigator decides to stop treatment for reasons such as side effects or other health conditions. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, additional cancer treatments, and any ongoing or new side effects. During the study, patients will undergo assessments according to established prostate cancer clinical trial criteria to evaluate their response to treatment. Researchers will monitor the time until disease progression or death for up to 18 months as the main outcome. Safety and treatment effects will be tracked through scheduled visits, laboratory tests, and imaging. The long-term follow-up will help understand survival outcomes and the impact of subsequent treatments over many years.

This research aims to improve understanding of rare autoinflammatory diseases (AID), which cause repeated inflammatory episodes without infection or cancer. The study focuses on hereditary periodic syndromes (monogenic AID) caused by gene mutations, as well as related polygenic or multifactorial AID like Behcet's disease, Still disease, Schnitzler's disease, PFAPA syndrome, chronic recurrent multifocal osteomyelitis, non-infectious uveitis and scleritis, spondyloarthritis, and Castleman disease. The goal is to gather detailed clinical and therapeutic data to expand knowledge of these rare conditions, which are often difficult to diagnose outside specialized centers. Participants will be enrolled in the AIDA international registry, which uses a secure online platform to collect retrospective and prospective information. Data collected include demographics, genetics, clinical features, laboratory and radiologic results, treatments, and socioeconomic impact. The registry covers multiple specific AID types and will track patients over at least 10 years through routine clinical visits usually every 3-6 months. The platform supports data sharing and analysis to identify disease patterns, treatment responses, and long-term outcomes. During the study, patients' medical records will be regularly updated with clinical and laboratory data. Researchers will analyze changes in patient numbers and disease characteristics over time. The registry also aims to foster international collaboration, improve early diagnosis, assess quality of life and socioeconomic effects, and support future research and clinical trials. Patient data privacy is maintained by using pseudonyms and complying with data protection laws throughout the study.

Prostate cancer is the most common cancer among men in industrialized countries like France, with over 60,000 new cases each year, and it is a leading cause of cancer-related deaths. This research investigates the possible link between exposure to chlordecone, a pesticide used in the French West Indies until 1993, and the risk of developing prostate cancer, particularly in Martinique where prostate cancer rates are notably higher. Previous studies suggest that both genetic and environmental factors, including pesticide exposure, may influence prostate cancer risk in this population. The study is designed as a case-control investigation involving men newly diagnosed with prostate cancer, as well as two control groups: men with negative prostate biopsies after elevated PSA tests, and men with normal PSA levels. Participants will be recruited over a 36-month period in Martinique. During a single inclusion visit, researchers will collect blood samples to measure chlordecone exposure and administer questionnaires. Analysis of the association between chlordecone levels and prostate cancer risk will be conducted after recruitment ends. Participants will provide blood samples and complete questionnaires during one study visit. Researchers will measure chlordecone levels in blood and evaluate the connection to prostate cancer risk. The study will also gather information on demographic and health factors. Results will be analyzed at the end of the recruitment phase to better understand the impact of environmental pesticide exposure on prostate cancer development in this population.

Researchers are investigating suicidal behaviors and risk factors in French overseas territories including French Polynesia, La Reunion, French Guiana, and Martinique, compared with a site in mainland France (Amiens). This study aims to improve understanding of suicide by combining quantitative and qualitative methods through psychological autopsies, which help identify mental disorders and socio-cultural factors linked to suicide. The study involves interviews with relatives of individuals who died by suicide. Data are collected using various questionnaires and evaluation tools including a Life Trajectory questionnaire, anthropological assessments, psychiatric diagnosis interviews (SCID), socio-demographic surveys, suicide risk evaluations, and emotional state questionnaires. The project will last 24 months, with a recruitment target of up to 30 cases per site. Inclusion interviews occur between 2 and 11 months after the suicide, followed by a 1-month follow-up interview. Participants will be involved in interviews and assessments throughout the study. Researchers will evaluate risk factors and mental disorders using structured clinical interviews. The follow-up interview aims to provide support to bereaved relatives and assess the impact of the psychological autopsy process. The total participant involvement per case is about one month after inclusion, and the study includes comprehensive monitoring of psychological and cultural factors related to suicide.

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.

Dat'AIDS Prevention is a cohort study conducted across more than 23 HIV sites in France, including overseas locations. It aims to describe all aspects of HIV prevention such as HIV screening, screening for sexually transmitted infections (STIs) and hepatitis, as well as the use of post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP). The study focuses on individuals seeking HIV prevention services to better understand prevention efforts in these settings. Participants include HIV-negative men and women aged 18 years and older attending for various services such as HIV screening, hepatitis screening, STI screening and treatment, exposure to blood, body fluids or sexual contact, and use of PEP or PrEP. Those who agree to participate provide signed consent to be included in the study. Throughout the study, researchers will track the number of patients enrolled for HIV prevention from the date of enrollment through to study completion, which lasts about one year on average. Participants will be monitored during this period to gather data on prevention practices and outcomes, supporting a comprehensive understanding of HIV prevention in France.

Dengue fever, spread by the Aedes mosquito, is a major health concern in tropical and subtropical areas. There is no antiviral treatment, and controlling the mosquito vector has been challenging. The 2018 approval of the Dengvaxia4 tetravalent chimeric yellow fever/dengue vaccine for people aged 9 to 45 years with prior dengue infection marks significant progress. However, data on dengue virus presence in children aged 9 to 17 years in the French Caribbean islands of Martinique and Guadeloupe is lacking, prompting this study to estimate dengue seroprevalence in this age group. This study involves children aged 9 to 17 years receiving care at hospital departments in Martinique and Guadeloupe. Blood samples will be collected during routine care to test for dengue virus antibodies. Alongside this, a survey will assess parents' acceptance of the dengue vaccine, especially Dengvaxia4. The study also considers the impact of past Zika virus infections in the region, which may affect vaccine response and diagnosis, by conducting a joint seroprevalence study of dengue and Zika viruses. Participants will be monitored through blood tests to measure dengue seroprevalence over about one year. The study also collects data on vaccine hesitancy from parents or legal guardians. The results aim to guide optimal dengue vaccination strategies for children in these areas, improve healthcare planning for future outbreaks, and support the development of better diagnostic tests. The study duration corresponds to the completion of the seroprevalence measurement, roughly one year.

Researchers are studying the effects of Bothrops snake bites on plasma Willebrand factor activity in people bitten in Martinique and French Guiana. These snake bites can cause severe local and systemic symptoms, including pain, swelling, bleeding, and blood clotting problems. The study aims to understand how different Bothrops species cause varying effects on blood clotting and endothelial activation, which may help tailor treatments for these envenomations. Participants who have been bitten by Bothrops snakes and admitted to hospitals in Martinique or French Guiana will have additional blood samples taken during routine care for research purposes. The study involves measuring the activity of plasma Willebrand factor before administering anti-venom treatments like Bothrofav® or Antivipmyn-tri®. The additional blood taken is a small volume and considered low risk. During the study, researchers will collect clinical data and blood samples to evaluate coagulation and endothelial function. They will monitor the severity of envenomation, including local swelling and systemic symptoms. The main outcome measured is plasma Willebrand factor activity at hospital admission. The study seeks to clarify how changes in this factor contribute to either bleeding or clotting complications, with the goal of improving individualized treatment approaches.

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.