Auxerre

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 exploring a treatment approach for women with early-stage hormone receptor-positive, HER2-negative breast cancer who face an intermediate risk of cancer recurrence. This phase III trial builds on previous findings that adding the drug ribociclib, a CDK4/6 inhibitor, to standard hormone therapy after surgery can extend the time patients remain free from invasive disease. The study aims to see if using ribociclib allows some patients to avoid chemotherapy and its side effects without compromising treatment effectiveness. Participants will either receive chemotherapy followed by hormone therapy combined with ribociclib or a de-escalated treatment plan that reduces or omits chemotherapy while still using ribociclib and hormone therapy. Ribociclib will be administered for three years as part of the adjuvant treatment after surgery. The study is designed to reflect routine clinical practices for deciding chemotherapy eligibility, using standard pathological assessments and genomic tests. Throughout the trial, women will undergo regular monitoring, including clinical visits, laboratory tests, and heart function assessments, to ensure safety and treatment adherence. Researchers will measure invasive breast cancer-free survival over a period of up to 12 years from randomization. The study also tracks patients' ability to comply with treatment schedules and evaluates long-term outcomes to confirm if chemotherapy can be safely reduced or avoided in this group.

Some patients experience noises like clicking, snapping, cracking, or popping after a total knee replacement, but it is unclear if these noises relate to worse outcomes. Previous studies have shown mixed results about whether noise affects patient satisfaction or symptoms after surgery. This research compares the occurrence of such noise between two types of total knee replacements in adults with knee osteoarthritis. The study compares an ultra-congruent total knee prosthesis (Score 2, Amplitude) to a posterior-stabilized total knee prosthesis (Anatomic, Amplitude) in patients undergoing total knee arthroplasty. Both groups receive knee replacement surgery aiming to treat end-stage osteoarthritis. The key focus is on the patient-perceived noise from the replaced knee joint. Participants will be assessed for the presence of articular noise over a 2-year period following their knee replacement. Researchers will monitor and record this noise as a primary outcome to understand its prevalence with each prosthesis type. The study includes adults able and willing to comply with the protocol and who have signed informed consent. Safety and compliance will be carefully tracked throughout the study duration.

Researchers are evaluating the use of the ANTHÉLIA intense pulsed light (IPL) medical device to treat various skin disorders including excessive hairiness (such as hirsutism and hypertrichosis), vascular lesions like rosacea, pigmented lesions including lentigo and melasma, and acne vulgaris. The IPL device has been FDA-cleared since 1995 and is known for its cost-effectiveness and versatility compared to single-spectrum lasers, leading to its widespread use in different clinical settings. Participants in this study receive treatment with the ANTHÉLIA IPL device designed to target these skin conditions. The device is used on affected areas such as legs, arms, bikini line, axilla for hairiness; face and limbs for vascular lesions; cheeks, back, hands, arms, and legs for pigmented lesions; and the face for acne vulgaris. Treatments are scheduled and monitored up to 18 months for excessive hairiness and up to 4 months for vascular lesions, pigmented lesions, and acne. During the study, participants undergo regular evaluations to assess the effectiveness of the treatment on their skin condition. Researchers measure outcomes related to the reduction of excessive hairiness, improvement of vascular and pigmented lesions, and acne severity. Participants are monitored for safety and adherence, including protection from sun exposure during and after treatment for acne patients. The total observation period varies depending on the condition being treated, with follow-up extending up to 18 months for some outcomes.

Researchers are evaluating a new way to give immunotherapy for adults with metastatic non-squamous lung cancer. This phase III randomized study compares a longer interval between pembrolizumab infusions as maintenance treatment against the usual schedule. Both groups may receive pembrolizumab alone or combined with pemetrexed, depending on eligibility and absence of contraindications. In the experimental Pulse arm, patients receive pembrolizumab 200 mg every 6 weeks plus pemetrexed 500 mg/m² every 3 weeks if appropriate. In the Control arm, patients get pembrolizumab either 200 mg every 3 weeks or 400 mg every 6 weeks, also with pemetrexed 500 mg/m² every 3 weeks when suitable. This study tests whether the longer dosing interval is not worse than the standard approach for maintenance therapy. Participants undergo regular evaluations including scans and clinical assessments to measure overall survival over 6 years. Eligibility checks include lung cancer diagnosis, prior induction therapy, and health status. Safety monitoring and follow-up continue throughout the study to track treatment effects and patient well-being.

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.

Researchers are evaluating the effect of combining Regorafenib with metronomic chemotherapy and low-dose aspirin versus using standard Regorafenib treatment alone in patients with metastatic colorectal cancer that is resistant to chemotherapy. This phase 2 study aims to compare the progression-free survival between these two treatment approaches to understand if the combination offers any benefit. Participants receive Regorafenib following a special dosing schedule called "REDOS" during the first cycle, gradually increasing doses over three weeks then taking a week off. After the first cycle, the dose is adjusted based on tolerance. In the combination group, patients also take daily metronomic chemotherapy drugs cyclophosphamide and capecitabine for six months, along with low-dose aspirin until disease progression. The treatment continues until unacceptable side effects or cancer progression. During the study, participants undergo blood samples for plasma and circulating tumor DNA, as well as fresh tumor biopsies at baseline and week 8. Quality of life is assessed repeatedly using specific questionnaires at multiple time points up to one year and at treatment end and follow-up visits. Researchers monitor progression-free survival as the primary outcome, with safety and treatment tolerability tracked throughout. The total study duration includes treatment and follow-up phases, ensuring comprehensive assessment of effects and patient well-being.

Calciphylaxis is a rare and painful condition causing ischemic skin lesions due to blocked small blood vessels, mainly affecting patients with end-stage renal disease on hemodialysis. Researchers are conducting a prospective randomized controlled trial to evaluate the safety and effectiveness of adding rheopheresis treatment to standard care for these patients. Rheopheresis is a procedure using double-filtration plasmapheresis to remove specific high molecular weight proteins involved in inflammation and blood clotting. Participants will be randomly assigned to receive either rheopheresis or a sham-apheresis as an additional treatment alongside standard care. Rheopheresis is performed using an automated device (Plasauto) that filters plasma in a double-filtration process, while sham-apheresis uses the same device but returns untreated plasma to the patient. A total of 17 treatment sessions are planned over 12 weeks. During the study, participants will be monitored for complete healing of their calciphylaxis-related skin lesions after 12 weeks of treatment. The trial includes assessments of wound healing progress and safety measures. Participants must be adults on hemodialysis with calciphylaxis lesions, and the study aims to determine if rheopheresis improves healing compared to standard care alone.

Researchers are evaluating the plasma levels of various multikinase inhibitors in patients with advanced digestive cancers, including gastrointestinal stromal tumor (GIST), metastatic colorectal cancer (mCRC), hepatocellular carcinoma (HCC), gastroenteropancreatic neuroendocrine tumor (gepNET), and pancreatic neuroendocrine tumor (pNET). This phase IV, national, multicenter, open-label study aims to determine the optimal drug dose tailored for each patient in the future by monitoring drug concentrations in the blood. Participants receive standard treatments with different drugs depending on their cancer type, such as regorafenib, everolimus, sunitinib, cabozantinib, or the combination of encorafenib and cetuximab. Blood samples are collected at baseline, one month, and two months after starting treatment, and additionally if specific adverse events or disease progression occur. These samples help build a pharmacokinetic model to assess drug exposure levels. During the study, patients are monitored according to usual care guidelines, with evaluations including tumor measurements as per local practice. Researchers track trough drug concentrations throughout treatment for up to four years. Patient follow-up includes safety assessments and vital status checks. Participation involves regular blood sampling and clinical monitoring to gather data on drug dosing and patient response over time.