Meaux

This research aims to evaluate antibiotic treatments for acute pyelonephritis AP in children aged 1 month to 3 years. It compares a shorter intravenous IV antibiotic course of 3 days alone to a longer treatment consisting of 3 days IV followed by 7 days of oral antibiotics. The goal is to see if the shorter IV treatment is as effective in curing AP and preventing recurrence and renal scarring, while reducing the risk of antibiotic resistance and preserving gut microbiota diversity. Participants are randomly assigned to one of two groups. The experimental group receives only 3 days of IV antibiotics with ceftriaxone andor amikacin, after which treatment is stopped. The control group receives the usual care of 3 days IV antibiotics followed by 7 days of oral antibiotics, either cotrimoxazole or cefixime. The study includes collection of fecal or rectal swabs and blood tests to assess microbiota and resistance. Treatment effectiveness and safety are compared between groups. During the study, children are monitored for fever, symptoms, and urine cultures to confirm infection clearance. Researchers measure recurrence of febrile urinary tract infections within 28 days after treatment ends and follow clinical cure at 10 or 17 days depending on the group. Additional assessments include monitoring recurrence at 90 days, antimicrobial resistance in gut bacteria, and intestinal microbiota diversity over about a month. Participation lasts through treatment and follow-up visits up to several weeks.

Researchers are investigating metastatic colorectal cancer mCRC patients who have a specific genetic change called the BRAFV600E mutation. This rare subtype of mCRC often shows poor response to current treatments and has a generally poor outlook. The study aims to collect detailed clinical data and biological samples to better understand this condition, including how patients respond to treatments and what factors predict their survival. It focuses on real-world treatment outcomes and biological markers that might influence therapy choices and resistance. Participants will provide blood samples at multiple times during their treatment, including before and during the first three treatment cycles, at 3 and 6 months after starting each treatment line, and when disease progression occurs following certain therapies. The study gathers up to 390 mL of blood per participant over time to analyze circulating tumor DNA and immune environment factors. This observational approach will help researchers identify biomarkers related to treatment response and disease progression. During the study, participants clinical progress and survival will be tracked for up to five years. Researchers will review overall survival from diagnosis to death and assess how prognostic markers relate to progression-free survival and response to treatments. The study involves collecting tumor tissue samples and blood tests, along with routine follow-up visits. All data collected will contribute to understanding BRAFV600E mCRC and improving future treatment strategies.

Non-muscle-invasive bladder cancer NMIBC is a type of bladder tumor that affects the inner lining of the bladder without invading the muscle layer. This research aims to collect and analyze real-world data on how NMIBC is managed and followed up in clinical practice across France. The study seeks to assess the performance of urine tests used to detect tumor recurrence and to understand variations in treatment and patient outcomes. The study is observational and involves collecting medical data from patients being monitored for NMIBC, including results from urine biomarker tests done before biopsies or resections. Urologists participating in the French Urology Association will record findings from regular bladder endoscopic exams and urine test results during routine care visits. Data analysis will focus on the accuracy of urine tests in predicting tumor recurrence and how this varies by tumor characteristics and prior treatments. Participants will have their medical history, treatments, and urine test results entered into a registry at enrollment. During follow-up visits scheduled as part of their personalized care, data on bladder exams and urine tests will be collected. Researchers will evaluate outcomes such as recurrence-free survival and the diagnostic value of urine biomarkers over a five-year period. The study plans to include around 8,000 patients over six years to improve understanding of NMIBC management and follow-up.

Researchers are studying advanced non-small cell lung cancer NSCLC with ALK gene rearrangement treated with next-generation tyrosine kinase inhibitors TKIs as first-line therapy. This prospective study, part of the national EXPLORE ALK cohort, aims to understand the biological characteristics and resistance mechanisms of this cancer type. It involves patients with stage IIIB or IV NSCLC who are not eligible for curative locoregional treatment and have confirmed ALK rearrangement. The study collects tumor tissue samples at diagnosis and at disease progression, if available, to analyze ALK fusion partners, variants, and co-mutations using RNA sequencing. Blood samples are taken at diagnosis, first tumor evaluation, and disease progression to analyze circulating tumor DNA ctDNA with next-generation sequencing. Treatments studied include alectinib, brigatinib, lorlatinib, and entrectinib, either marketed or under early access programs. Participants provide blood samples and allow use of tumor tissue for centralized biological analyses. Researchers measure progression-free survival up to 72 months as the primary outcome, along with overall survival, response rates, duration of response, ctDNA clearance, and resistance mechanisms associated with treatment and ALK fusion partners. The study involves regular evaluations over several years to monitor treatment outcomes and biological changes.

Researchers are studying ways to reduce the duration of immunotherapy treatment in patients with advanced non-small cell lung cancer NSCLC who have their disease controlled after initial treatment. The study focuses on comparing a shorter immunotherapy maintenance period of 6 months to the usual 2 years to see if less treatment can still be effective. This phase II-III randomized study enrolls patients with stage IV NSCLC who have not received prior treatment for advanced disease. Participants will first receive a combination of chemotherapy and pembrolizumab for about 6 months, using specific chemotherapy drugs based on their cancer type. After this induction, patients showing disease control without severe side effects will be randomly assigned to one of two groups continuing pembrolizumab with or without pemetrexed for certain cancer types for up to 2 years or observation with or without pemetrexed. Researchers will monitor various factors including patient characteristics and tumor markers. During the study, participants will attend scheduled visits for treatment and monitoring, including imaging scans to measure tumor response and laboratory tests to check health status. Quality of life and survival will be tracked up to about 24 months after randomization. The study also collects data on side effects and progression-free survival to better understand the benefits and risks of shorter versus longer immunotherapy maintenance.

Researchers are studying how to adjust the dose of fluoropyrimidine chemotherapy based on uracilemia levels in patients with DPD deficiency who have gastrointestinal cancers. This phase II multicenter trial aims to find the best dose reduction strategy to reduce side effects while treating digestive cancers. The main question is which dose reduction is needed for patients with this enzyme deficiency. Participants will receive chemotherapy with doses adjusted according to their uracilemia level. Patients with low uracilemia <16 ngmL will get the full dose, while those with higher levels will receive varying dose reductions or random assignments between 25% and 50% reductions depending on their uracilemia range. Treatments include the FOLFOX or CAPOX chemotherapy regimens, given in cycles every 2 to 3 weeks. During the study, participants will visit the clinic every 2 to 3 weeks for checkups and tests to monitor side effects and treatment response. Researchers will measure the occurrence of serious blood and gastrointestinal toxicities after two treatment cycles and track dose adjustments, toxicity, and survival outcomes over several months and years. The study involves close monitoring of health and treatment effects for up to three years, depending on cancer stage.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are conducting a phase 3, open-label, randomized study in adults aged 18 to 69 with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation ASCT and high-dose chemotherapy. The trial aims to evaluate the effectiveness and safety of using elranatamab and lenalidomide as alternatives to standard chemotherapy in the consolidation phase, and to compare elranatamab alone with standard maintenance therapies. This study involves about 824 patients across approximately 70 sites and addresses important outcomes like minimal residual disease MRD negativity, progression-free survival, and overall survival. Participants receive standard induction therapy with four cycles of D-VRd daratumumab, bortezomib, lenalidomide, dexamethasone followed by either ASCT and D-VRd consolidation standard arm or elranatamab with lenalidomide consolidation experimental arm. After consolidation, patients enter a maintenance phase where they are re-randomized to receive either daratumumab plus lenalidomide or elranatamab monotherapy for about two years. Treatment adjustments depend on MRD status and disease progression during maintenance. Throughout the study, participants undergo regular assessments including disease evaluations and safety monitoring. Researchers measure MRD negativity rates, progression-free survival, overall survival, adverse events, and quality of life using validated questionnaires. The trial offers long-term follow-up, lasting up to around 10 years, to capture comprehensive data on treatment effects and patient well-being.

Large-cell neuroendocrine carcinomas LCNECs of the lung are rare, aggressive tumors with poor prognosis and limited treatment options. Researchers are evaluating the combination of durvalumab with etoposide and platinum chemotherapy as a first-line treatment to improve the progression-free rate at 12 months in patients with advanced LCNEC confirmed by expert pathologist review. This phase II, multicenter, open-label study aims to assess the efficacy and safety of this combination compared to historical data. Participants will receive durvalumab combined with etoposide and either cisplatin or carboplatin. Treatment includes an induction phase with cycles every three weeks for 12 weeks four cycles, followed by a maintenance phase with durvalumab every four weeks for up to 24 months. This prospective study uses an external control arm for comparison and focuses on first-line treatment of advanced LCNEC. During the study, patients will be closely monitored through scheduled visits and assessments, including radiological evaluations to measure disease progression. Researchers will track the progression-free rate at 12 months as the primary outcome and also evaluate objective response rates, disease control rates, overall survival, and safety profiles over a period of up to 63 months. Participants will be followed for adverse events and treatment-emergent effects for up to 27 months and 90 days post-treatment, ensuring comprehensive safety and efficacy evaluation.

Researchers are studying patients who have lived for three years or more after being diagnosed with metastatic lung cancer and who are no longer receiving cytotoxic chemotherapy. The study aims to understand these patients clinical characteristics, health status, socioeconomic impacts, quality of life, and their ability to return to work. This observational research focuses on both non-small cell lung cancer NSCLC and small cell lung cancer SCLC. Participants will be observed over time without receiving experimental treatments. They will complete several questionnaires related to quality of life, anxiety, and depression at the start of the study, then at 6 and 12 months, and annually for up to five years. Their health and treatment history, including any ongoing therapies like immunotherapy or targeted therapy, will be recorded throughout the study. During the study, participants will continue their usual medical care and attend regular consultations as needed. Researchers will collect data through questionnaires and health evaluations to measure clinical characteristics, health status, socioeconomic factors, and psychological well-being. The main outcomes include baseline clinical data and repeated assessments over five years to better understand long-term survivorship after metastatic lung cancer diagnosis.