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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.

Minimally invasive surgery has greatly changed surgical practices since the 1980s, especially in urology where laparoscopy and robot-assisted surgery have advanced treatment of conditions like prostate cancer. In France and other countries, robotic surgery became widespread without strong studies confirming its benefits or guidelines on quality and access. This trial aims to carefully evaluate robot-assisted prostate removal compared to traditional laparoscopic and open surgery techniques to provide clear evidence for patients and healthcare decision-makers. Participants will undergo radical prostatectomy using one of three approaches: robot-assisted laparoscopy, conventional laparoscopy, or open surgery (laparotomy). Urinary and erectile functions will be assessed before and after surgery to compare outcomes across the three groups. This large prospective study is conducted at multiple centers to gather reliable data on the benefits and impacts of each surgical method. During the study, patients will be evaluated for urinary function using the EPIC 50 score 45 days after surgery. Researchers will also assess erectile and urinary functions before and after the prostatectomy. The study focuses on understanding how each surgical technique affects recovery and function, helping to inform patients and health authorities about the real advantages of robot-assisted surgery. Participants must be hospitalized for planned radical prostatectomy and will be monitored throughout their treatment and recovery.

Researchers are evaluating adult patients diagnosed with idiopathic retroperitoneal fibrosis (IRF) in a prospective multicenter study. The study focuses on using prednisone steroid treatment and aims to compare the relapse rate of IRF 12 months after stopping steroids. The study involves patients with active or relapsing IRF confirmed by symptoms, elevated CRP levels, and imaging showing a retroperitoneal peri-aortic mass. Participants receive prednisone orally at a dose of 1mg/kg/day for a period ranging from 9 to 21 months. Before treatment, patients undergo standard clinical assessments including abdominal CT scans, blood and urine tests, and an 18F-fluorodeoxyglucose PET/CT scan. Based on PET/CT results, patients with higher disease activity receive steroid treatment with a tapering schedule, while those with low activity are excluded. Follow-up visits occur at 6, 9, 12, 15, and 21 months, with assessments including clinical exams, imaging, and laboratory tests. Patients who fail to achieve remission or require higher steroid doses by month 9 are excluded from the study. During the study, researchers monitor clinical signs, vital signs, steroid compliance, medication use, and adverse events. Imaging and biological tests are repeated throughout follow-up to assess disease status. The primary outcome is the cumulative relapse rate 12 months after stopping steroid treatment. Safety and treatment effectiveness are closely observed over the treatment and follow-up periods to evaluate early steroid discontinuation in selected patients.

Researchers are evaluating the consistency of the EMOCARE emotional monitoring software compared to commonly used questionnaires in assessing emotional states in patients with mild to moderately severe depressive episodes. The study aims to determine whether EMOCARE provides results that align with tools like PHQ-9, MADRS, GAD-7, BDI-II, and EQ-5D-5L, and to understand patients' experiences using passive monitoring software without active involvement. This prospective, multicenter, single-blind clinical investigation focuses on adults with major depressive disorder. Participants will use the EMOCARE software on their digital devices such as smartphones or computers, with the ability to activate or deactivate it anytime during the 6-week follow-up. The study includes two scheduled visits six weeks apart, during which participants complete various questionnaires and have consultations with the doctor. Additional assessments include self-administered questionnaires at 2 and 4 weeks post-first appointment and a follow-up phone call at 3 weeks to check on participants' wellbeing. Participants are also asked to keep a diary of symptoms, medical consultations, and medication changes. Throughout the study, researchers will monitor changes in EMOCARE scores and PHQ-9 results from baseline to six weeks. Data collection includes clinical screenings, questionnaires, doctor interviews, and symptom diaries. The study focuses on understanding emotional state assessments and patient experiences over the 6-week period, ensuring participant safety and compliance with protocol requirements.

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.

Colorectal cancer mainly affects elderly patients, with over half of new cases in France occurring in those aged 70 or older. Adjuvant chemotherapy has shown benefits in disease-free and overall survival after stage III colon cancer surgery, but its use in elderly patients remains limited. This phase III randomized study explores whether adjuvant chemotherapy improves disease-free survival in elderly patients and which chemotherapy regimen is most effective, addressing concerns about benefits for both unfit and fit elderly patients. Participants will be divided into two groups based on a multidisciplinary evaluation including a geriatrician. One group will receive fluoropyrimidine-based chemotherapy (LV5FU2 or capecitabine), and the other will receive oxaliplatin-based chemotherapy (FOLFOX4 or XELOX). Some patients may be assigned to observation only. Treatments will begin within 12 weeks after surgery. The study also evaluates specific biological markers common in elderly tumors, such as mismatch repair deficiency. During the study, participants will undergo assessments including geriatric questionnaires and medical monitoring. Researchers will track disease-free survival over three years following the last patient's enrollment. Safety and treatment effects will be monitored, with exclusion of patients expected to live less than four years or those unable to comply with follow-up. The study aims to better understand chemotherapy benefits in an elderly population after colon cancer surgery.

This research aims to observe patients in France who have HER2-negative early breast cancer and are treated with olaparib. The study focuses on understanding how many patients complete the full planned course of olaparib treatment, which is given as adjuvant therapy following initial cancer treatment. It is a national, multicenter, prospective cohort study conducted without altering the usual care provided by doctors. Patients enrolled will be those starting adjuvant olaparib treatment based on their doctor's decision. There are no experimental interventions or treatment changes imposed by the study. The study captures real-world use of olaparib across multiple centers in France. Participants will be followed for at least 18 months after joining the study to see if they complete the full duration of olaparib treatment. Researchers will collect data on treatment adherence and other relevant clinical information during this period. The main outcome measured is the proportion of patients who receive olaparib for the entire planned treatment period.

Researchers are studying the long-term health outcomes of people living with HIV who are treated with antiretroviral therapy (ART). While ART has helped make HIV a chronic condition with survival rates close to the general population, those living with HIV still face higher risks of other health problems, including immune system issues, cardiovascular disease, cancer, and complications from aging. The study also looks at psychiatric, neurological, and social factors affecting these individuals, aiming to better understand overall health beyond just physical symptoms. Participants in this study receive follow-up care based on national guidelines, where demographic, clinical, biological, and treatment data are collected at each hospital visit using a standardized questionnaire. All health events are recorded according to the International Classification of Diseases (ICD-10). Additionally, a biobank of samples is collected from consenting participants at entry and every two years thereafter to support further research. People in the study will be monitored for up to four years, with annual assessments of socio-demographic characteristics and health status. The study tracks the development of new health problems, monitors the effectiveness and side effects of ART regimens, and gathers comprehensive data on participants’ clinical management. This long-term observation aims to provide a detailed understanding of morbidity and mortality risks in treated HIV patients.

Lower limb trauma requiring immobilization is a very frequent condition that is associated with an increased risk of developing venous thromboembolism (VTE). The TRiP(cast) score has been developed to provide individual VTE risk stratification and help in thromboprophylactic anticoagulation decision. The recent CASTING study had confirmed that patients with a TRiP(cast) score \<7 have a very low risk of VTE and could be safely manage without prophylactic treatment. Conversely, patients with a score ≥ 7 have a high-risk of VTE and require a prophylactic anticoagulant treatment. Low molecular weight heparins (LMWH) have been shown to be effective in this indication. However, in the CASTING study, the 3-month symptomatic VTE rate was 2.6% in this subgroup despite LMWH prophylactic treatment. This result suggests that LMWH are not sufficiently effective in this particular subgroup of high-risk patients. Direct oral anticoagulants, and in particular rivaroxaban, may be an effective and safe alternative to LMWH. In the PRONOMOS study, comparing LMWH with rivaroxaban in patients who had undergone non-major lower limb surgery, the relative risk of symptomatic VTE was 0.25 (95% CI = 0.09 - 0.75) in favor of rivaroxaban 10mg. No significant increase in bleeding was found. In addition, as LMWH treatment requires subcutaneous daily injections, the use of rivaroxaban may positively impact patients' quality of life as well as being effective in medico-economic terms. The aims of this study are to demonstrate that rivaroxaban is at least as effective, easier to use and more efficient than LMWH in patients with trauma to the lower limb requiring immobilisation and deemed to be at risk of venous thromboembolism (TRiP(cast) score ≥ 7). High-risk patients are randomized to receive either rivaroxaban or LMWH. They are followed up at 45 days and 90 days to assess the occurrence of thrombotic events or bleeding, as well as their satisfaction with the treatment received.

Researchers are investigating the best way to screen for hidden cancers in patients aged 50 years or older who have been newly diagnosed with unprovoked venous thromboembolism (VTE), which includes deep vein thrombosis or pulmonary embolism. VTE can sometimes be the first sign of an undetected cancer, and identifying such cancers early may improve patient care. Previous studies showed that patients over 50 have a higher chance of having an occult cancer compared to younger patients, and imaging with FDG PET/CT might help detect these cancers more effectively. The study compares two screening methods: a limited cancer screening involving medical history, physical exams, blood tests, chest X-rays, and gender-specific cancer screenings, and an extensive screening that adds a whole-body FDG PET/CT scan to the limited screening. This FDG PET/CT scan is a diagnostic imaging technique commonly used for cancer detection and staging. Participants will be randomly assigned to either group to see if the addition of FDG PET/CT reduces the number of cancers missed over one year. During the study, participants will undergo the assigned screening procedures and be followed up for one year to monitor for any hidden cancers that were not initially detected. Researchers will evaluate the effectiveness of each screening strategy based on the number of occult cancers missed at one year. Regular assessments include medical exams, laboratory tests, and imaging as described, ensuring patient safety and accurate data collection throughout the follow-up period.