Meaux

Researchers are studying acute pyelonephritis (AP), a common bacterial kidney infection in children, focusing on those aged 1 month to less than 3 years without prior urological malformations. The study compares a short 3-day intravenous (IV) antibiotic treatment alone to a 3-day IV treatment followed by 7 days of oral antibiotics. The goal is to see if the shorter IV-only treatment is as effective at preventing infection recurrence and long-term kidney scarring, while possibly reducing antibiotic resistance and preserving gut microbiota diversity. Participants receive either IV ceftriaxone and/or amikacin once daily for 3 days, or the same 3-day IV treatment followed by 7 days of oral cotrimoxazole or cefixime. The study includes procedures like procalcitonin testing and fecal or rectal swabs collected at several points during and after treatment (day 0, 3, 10 or 17, and 31 or 38) to monitor bacterial presence and gut microbiota changes. Treatment begins after initial confirmation of infection and favorable early response. During the study, children are closely monitored for infection recurrence 28 days after completing antibiotics. Assessments include clinical evaluations, urine cultures, and monitoring for any adverse effects. The total participation covers treatment and follow-up periods to ensure safety and measure outcomes such as infection recurrence and bacterial resistance. This is a Phase 4 open-label randomized trial conducted across multiple centers.

Researchers are studying patients with metastatic colorectal cancer (mCRC) who have a specific BRAFV600E mutation. This rare subtype of mCRC has poor prognosis and resistance to current treatments, especially in tumors with microsatellite stability or proficient mismatch repair. The study aims to collect detailed clinical data and biological samples to better understand treatment outcomes, resistance, and survival in real-world settings. Participants will provide blood samples and tumor tissue samples to support various research goals. The study will evaluate circulating tumor DNA during different lines of metastatic treatment to predict treatment response and resistance. It will also analyze the immune environment of BRAFV600E mCRC tumors and study specific subgroups with mismatch repair deficiencies. Clinical management data will be collected to inform future therapeutic approaches. During the study, patients will be monitored regularly with blood sample collections of 30 mL at each time point. Researchers will gather information about treatments, survival, and biological markers over time. The main outcome measured is overall survival from diagnosis up to five years. Patients must be able to comply with study procedures and provide informed consent. The study aims to improve knowledge of this aggressive cancer subtype and support development of new treatments.

Researchers are studying the management and follow-up of non-muscle-invasive bladder cancer (NMIBC), a type of bladder tumor that affects the inner lining and underlying tissue but not the muscle layer. This cancer type accounts for a significant portion of bladder cancer cases in France, with many patients experiencing tumor recurrence within five years. The study aims to evaluate the diagnostic accuracy of urine biomarker tests compared to bladder endoscopy, which is the current standard for detecting tumor recurrence. Additionally, it will describe tumor characteristics, patient history, treatments, and regional differences in care. Patients being monitored for NMIBC and undergoing routine care will have their medical details, including prior treatments and urine test results, recorded in a registry. Follow-up includes regular bladder endoscopy exams, with dates and findings noted by urologists. Urine test results taken before biopsies will also be tracked. This observational study will analyze the performance of urine tests by calculating sensitivity, specificity, and predictive values, and exploring differences based on tumor grade, stage, and previous treatments. The goal is to include 8000 patients across France over six years. Participants will provide data through medical records and routine exams during their personalized care plans. Urine samples and bladder fibroscopy results will be collected at each follow-up visit to assess test accuracy over a five-year period. Researchers will monitor recurrence-free survival and urine test performance, aiming to identify if urine tests can safely reduce the need for invasive cystoscopy. The study focuses on long-term monitoring to better understand and improve care for NMIBC patients.

Researchers are studying the biological features of advanced ALK-rearranged non-small cell lung cancer (NSCLC) in patients treated with new generation tyrosine kinase inhibitors (TKIs) as their first therapy. This study is part of the national EXPLORE ALK cohort, a multi-center observational project in France, focusing on patients with this specific genetic alteration. The goal is to better understand the tumor biology and resistance mechanisms by analyzing samples from diagnosis through disease progression. The study collects tumor tissue samples at diagnosis and, when possible, at disease progression for RNA sequencing to identify ALK fusion partners, variants, and co-mutations. Blood samples are also taken at diagnosis, first tumor evaluation, and at progression to analyze circulating tumor DNA (ctDNA) using next-generation sequencing panels that detect mutations, fusions, and other genetic changes. These biological analyses are centralized at specialized centers such as the Léon Bérard Center and Rouen University Hospital. Patients are treated with approved ALK inhibitors like alectinib, brigatinib, lorlatinib, or entrectinib as part of their standard care. Participants will provide blood samples at multiple time points and, if possible, tumor biopsy samples for detailed genetic analysis. Researchers will monitor the progression-free survival from treatment start for up to 72 months. The study involves regular evaluations to assess tumor status and collect biological material to track genetic changes over time. Consent for sample collection and participation in the study is required, and patient data is managed within the national health system framework.

Researchers are investigating a new approach to immunotherapy duration for patients with metastatic non-small cell lung cancer (NSCLC). This phase II-III randomized trial focuses on patients with stage IV NSCLC who have not received prior treatment for advanced disease. The study aims to compare the standard two-year immunotherapy maintenance with a shorter six-month (27-week) treatment period in patients who achieve disease control after initial chemo-immunotherapy induction, addressing the need to optimize treatment duration while maintaining disease control. Participants will first receive a combination of chemotherapy and pembrolizumab as initial treatment: either paclitaxel-carboplatin for squamous cell carcinoma (SCC) patients or pemetrexed-platinum for non-SCC patients, along with pembrolizumab every three weeks. After six months, patients who show disease control without severe toxicity will be randomly assigned to either continue pembrolizumab (with or without pemetrexed for non-SCC) until disease progression or unacceptable toxicity or complete two years of treatment, or to observation (with or without pemetrexed for non-SCC). Throughout the study, participants will undergo regular assessments including imaging to measure tumor response according to RECIST 1.1 criteria. Researchers will monitor overall survival at 18 months in phase II and about 24 months after randomization in phase III. Additional evaluations include performance status, PD-L1 expression, and safety monitoring. The total participation duration includes the initial six-month induction followed by the randomized maintenance or observation phase, allowing comprehensive evaluation of long-term outcomes and treatment impact.

Multicenter phase II trial evaluating different strategies of pre-specified fluoropyrimidine-dose adjustment according to \[U\] in DPD-deficient patients with gastrointestinal cancer.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are conducting a phase 3, multicenter, open-label, randomized study to evaluate new treatments for adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation (ASCT). The study aims to compare the effectiveness and safety of a combination of elranatamab and lenalidomide as a replacement for standard chemotherapy during the consolidation phase, and to assess elranatamab alone versus standard care during maintenance therapy. Participants will first receive standard induction therapy with four cycles of a drug combination called D-VRd. After this, they will be randomly assigned to either receive standard consolidation therapy involving high-dose chemotherapy and ASCT followed by D-VRd consolidation (Arm A), or elranatamab combined with lenalidomide for consolidation (Arm B). Upon completing consolidation, patients will be re-randomized to receive maintenance treatment with either lenalidomide alone (Arm C) or elranatamab alone (Arm D). During the study, participants will be monitored for treatment effects including minimal residual disease negativity at the end of consolidation, progression-free survival, and overall survival. The study involves various assessments including clinical evaluations, laboratory tests, and monitoring for disease progression or side effects. The entire treatment and follow-up period may last up to several years, allowing researchers to evaluate long-term outcomes and safety.

Large-cell neuroendocrine carcinomas (LCNECs) of the lung are rare and aggressive tumors included with small-cell lung cancers in a subgroup of high-grade pulmonary neuroendocrine tumors. Diagnosing LCNEC is challenging, and the prognosis for advanced cases is poor, with survival typically around 8 to 10 months. Researchers are evaluating the effectiveness of combining durvalumab with etoposide and platinum-based chemotherapy as a first-line treatment for advanced LCNEC, based on promising results from related lung and digestive cancer studies. Participants receive treatment with durvalumab combined with etoposide and either carboplatin or cisplatin. The treatment starts with an induction phase consisting of 4 cycles every 3 weeks for 12 weeks, followed by a maintenance phase with durvalumab every 4 weeks for up to 24 months. This open-label, multicenter phase II study uses an external control arm for comparison and aims to assess both efficacy and safety. Throughout the study, participants will undergo regular medical evaluations including imaging scans and laboratory tests to monitor disease progression and treatment effects. The primary outcome measured is the progression-free rate at 12 months. Safety and tolerability will also be monitored. Patients will be followed closely during treatment and maintenance phases, with scheduled visits every few weeks over a period extending up to two years.

Researchers are studying patients who have metastatic lung cancer and have survived for more than three years after their diagnosis without receiving cytotoxic chemotherapy. The focus is on understanding their clinical features, health status, quality of life, and socio-economic impacts, including the effects of cancer treatments, the occurrence of new diseases, and return to work. This observational study aims to better identify the needs of these long-term survivors to improve their management. Participants will complete several questionnaires, including the Hospital Anxiety and Depression Scale (HAD), the Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13), and the Aix-Marseille-University (AMU) questionnaire. These are designed to assess anxiety, depression, lung cancer symptoms, treatment side effects, and overall quality of life. Questionnaires are completed at the start of the study, at 6 and 12 months, and then yearly for up to 5 years. Participants will be followed during their regular medical consultations as per usual care at participating centers. Throughout the study, researchers will collect information on clinical characteristics, treatment details, health status, socio-demographic factors, and quality of life measures. Data will be gathered at baseline and during follow-up visits up to 5 years. This information will help assess the long-term impact of lung cancer and its treatments on patients who are living well beyond initial expectations.