Auxerre

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 studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

Researchers are evaluating the presence and perception of articular noise, such as clicking or popping sounds, in patients who have undergone total knee replacement surgery. The study aims to compare the prevalence of these noises between two types of knee prostheses an ultra-congruent total knee prosthesis Score 2, Amplitude and a posterior-stabilized total knee prosthesis Anatomic, Amplitude. This is important because previous studies have shown mixed results regarding the association between noise and patient discomfort or satisfaction after knee replacement. The study involves two groups receiving different types of total knee arthroplasty TKA. One group will receive the Score II ultra-congruent mobile-bearing cemented prosthesis designed to prevent femoral condyle subluxation during knee movement. The other group will receive the Anatomic posterior-stabilized fixed-bearing cemented prosthesis, which has a cam and post mechanism to provide knee stability. Only the cemented versions of both prostheses will be used in this randomized trial. Participants will be followed for up to two years, with assessments at one and two years after surgery. Researchers will measure the prevalence of articular noise, characterize the noise by discomfort, type, and location, and evaluate its impact on quality of life. Patient-reported outcome scores will also be collected. The study will monitor participant compliance and outcomes to better understand how these prosthesis designs affect noise perception and patient satisfaction over time.

Researchers are evaluating the Anthelia Intense Pulsed Light IPL medical device for treating various skin conditions including excessive hairiness, vascular lesions, pigmented lesions, and acne vulgaris. The study is a post-market clinical trial conducted to assess the devices effectiveness and safety in these skin disorders. The IPL device has been FDA-cleared since 1995 and is noted for its cost-effectiveness and versatility compared to single-spectrum lasers. Participants will receive treatment with the Anthelia IPL device during multiple visits, following the devices instructions for use. The treatments target unwanted hair, varicosities, rosacea, solar lentigines, and facial acne, with specific inclusion criteria for skin types and condition characteristics. The study includes follow-up periods ranging up to 18 months to evaluate treatment effects. During the study, participants will undergo assessments to measure effectiveness using scores such as IRBMS, DLQI, and ECLA for acne patients. Safety and treatment response will be monitored over periods from 4 to 18 months depending on the condition treated. Participants will be evaluated regularly to track improvements in hairiness, vascular and pigmented lesions, and acne, ensuring comprehensive monitoring throughout the trial.

Researchers are studying a new way to give immunotherapy as maintenance treatment for patients with metastatic non-squamous lung cancer. This phase III clinical trial compares a pulse dosing schedule with a conventional dosing schedule to see if the less frequent pulse dosing is not worse than the standard treatment. The study focuses on pembrolizumab alone or combined with pemetrexed as the maintenance therapy after initial chemotherapy and immunotherapy induction. Participants are randomly assigned to one of two groups. In the Pulse arm, pembrolizumab 200 mg is given every 6 weeks, and pemetrexed 500 mgm is given every 3 weeks if there is no contraindication. In the Control arm, pembrolizumab is given either 200 mg every 3 weeks or 400 mg every 6 weeks, plus pemetrexed 500 mgm every 3 weeks when appropriate. This treatment is given after patients have completed 3 or 4 cycles of induction therapy with pembrolizumab plus platinum and pemetrexed. During the study, participants will be monitored for overall survival over 6 years, along with progression-free survival, response duration, quality of life using several questionnaires, treatment tolerance, and economic factors. Researchers will also perform population pharmacokinetic analyses and study the drugs effect on immune cells. Patients will undergo regular assessments including clinical evaluations and laboratory tests to track treatment effects and safety throughout the study period.

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.

Colorectal cancer mostly affects elderly patients, with over half diagnosed at age 70 or older in France. This research evaluates the benefit of adjuvant chemotherapy after surgical removal of stage III colon cancer in elderly patients, focusing on whether fluoropyrimidine-based or oxaliplatin-based chemotherapy improves disease-free survival. The study addresses concerns about the effectiveness of chemotherapy in very elderly or unfit patients and includes an assessment of tumor biological factors common in the elderly. Participants are divided into two groups based on a doctors evaluation involving a geriatrician, with different randomization assignments. Treatments being studied include chemotherapy regimens with LV5FU2 or capecitabine and FOLFOX4 or XELOX, as well as observation. The chemotherapy is started within 12 weeks after surgery. The study compares these approaches to determine the best adjuvant chemotherapy strategy for elderly patients. During the study, participants undergo assessments including geriatric questionnaires and monitoring of toxicities. Researchers measure disease-free survival three years after the last patient joins, along with overall survival at five years. Safety is evaluated by observing side effects graded by standard criteria. The study excludes patients with less than four years expected survival and ensures medical follow-up is possible. Participation duration and detailed monitoring support evaluating chemotherapy benefits in this population.

Researchers are evaluating the effect of combining Regorafenib with metronomic chemotherapy capecitabine and cyclophosphamide and low-dose aspirin compared to standard Regorafenib treatment in patients with metastatic colorectal cancer who are resistant to chemotherapy. This phase 2 randomized trial aims to assess progression-free survival as the main outcome to better understand treatment impact in this patient group. Participants are assigned to one of two groups one receives Regorafenib alone, and the other receives Regorafenib plus metronomic chemotherapy and low-dose aspirin. Regorafenib is given 3 weeks out of every 4-week cycle, starting with a stepwise dosing schedule in the first cycle and then continuing at adjusted doses based on tolerance. The combination group receives cyclophosphamide daily for 6 months, capecitabine twice daily for 6 months, and aspirin daily until disease progression. During the study, participants undergo blood sampling for plasma and circulating tumor DNA analysis, fresh tumor biopsies at baseline and week 8, and complete quality of life questionnaires at multiple times including baseline and follow-up visits. Researchers monitor safety, treatment effects, and progression-free survival over time. The total participation duration varies depending on individual disease progression and tolerance to treatments.

Calciphylaxis, also called uremic calcifying arteriolopathy UCA, is a rare condition causing painful skin lesions due to small blood vessel calcification and clotting. This disease mainly affects patients with end-stage renal disease ESRD who require hemodialysis. Researchers are evaluating the safety and effectiveness of adding rheopheresis, a special blood filtration treatment, to the standard care for calciphylaxis in these patients through a prospective randomized controlled trial. In this study, participants will be randomly assigned to one of two groups. The experimental group will receive rheopheresis in addition to standard care, involving an induction phase of 3 sessions in the first week followed by 2 sessions weekly for 3 weeks, then a maintenance phase with 1 session per week up to week 11. The comparator group will receive sham-apheresis sessions on the same schedule, which mimics the procedure without actual filtration. Rheopheresis uses a machine to remove certain high molecular weight proteins from plasma to help treat microcirculation problems. Participants will be followed for 12 weeks during treatment with regular assessments of wound healing, pain levels, quality of life, antibiotic usage, hospital discharge days, survival, and inflammatory protein changes. The primary outcome is the percentage of patients achieving complete healing of calciphylaxis lesions after 12 weeks. Secondary outcomes include partial healing, new lesion occurrence, pain and analgesic use, and overall survival at 12 weeks and one year. Safety and efficacy data will help determine the added value of rheopheresis in calciphylaxis care.

Researchers are evaluating the plasma levels of various multikinase inhibitors in patients treated for advanced digestive cancers, including gastrointestinal stromal tumor, metastatic colorectal cancer, hepatocellular carcinoma, gastroenteropancreatic neuroendocrine tumor, and pancreatic neuroendocrine tumor. The study aims to determine the optimal drug dose for each patient in the future through detailed monitoring of drug concentrations. This is a Phase IV, national, multicenter, open, multi-cohort interventional study focused on improving personalized dosing strategies for these treatments. Participants are grouped by the specific treatment and cancer type they receive Regorafenib for metastatic colorectal cancer, gastrointestinal stromal tumor, and hepatocellular carcinoma Everolimus for gastroenteropancreatic neuroendocrine tumor Sunitinib for pancreatic neuroendocrine tumor and gastrointestinal stromal tumor Cabozantinib for hepatocellular carcinoma and the combination of Encorafenib and Cetuximab for metastatic colorectal cancer. Treatment and follow-up follow standard care guidelines, with blood samples collected at baseline, one month, two months after treatment start, during adverse events, and at disease progression to measure drug plasma levels. During the study, participants undergo blood sampling to assess drug concentrations and are monitored for disease progression and safety outcomes over up to four years. Researchers will evaluate trough drug concentrations as the primary outcome and track progression-free survival, overall survival, objective response rate, disease control rate, and drug toxicity as secondary outcomes. The study involves regular assessments and long-term follow-up to understand how drug levels relate to treatment response and safety.