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.

Researchers are investigating whether using a genetic test called Prosigna4 can help decide if chemotherapy is necessary for premenopausal women with hormone receptor-positive HR and HER2-negative breast cancer. This study aims to determine if treatment guided by this test produces similar outcomes to the standard approach of systematic chemotherapy. The trial focuses on younger women who often experience more side effects from chemotherapy, affecting their quality of life and work capacity. Participants will be randomly assigned to one of two groups. In the experimental group, treatment depends on the Prosigna4 score women with a high score above 60 will receive chemotherapy plus hormone therapy, while those with a lower score will receive only hormone therapy with ovarian suppression. The control group will receive the standard treatment of chemotherapy followed by hormone therapy. The study includes a pre-inclusion period for eligibility testing and randomization. Throughout the study, participants will complete questionnaires about quality of life, treatment side effects, emotional well-being, and other health measures for up to five years after randomization. Researchers will monitor cancer recurrence, survival, fertility, osteoporosis, cardiovascular disease, and other outcomes. Regular assessments include physical activity levels, adherence to therapy, and patient perceptions of treatment and participation, aiming to evaluate the safety and impact of treatment guided by the genetic test.

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.

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 MKIs in patients with advanced digestive cancers such as 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, multi-cohort interventional study aims to determine the optimal dose of these MKIs for each patient in the future. Participants receive treatment according to standard care for their specific cancer and MKI drug Regorafenib for mCRC, GIST, and HCC Everolimus for gepNET Sunitinib for pNET and GIST Cabozantinib for HCC and the combination of Encorafenib and Cetuximab for mCRC. Blood samples are collected at baseline, one month, and two months after treatment starts, as well as during adverse events or if disease progresses, to measure drug plasma concentrations and build pharmacokinetic models. During the study, participants are monitored through blood draws and tumor evaluations following local clinical practice. Researchers measure trough drug concentrations throughout treatment, along with progression-free survival, overall survival, response rates, disease control, and safety including drug toxicity for up to four years. This long-term follow-up helps understand treatment effects and drug exposure in advanced digestive cancer patients.