Troyes

Researchers are evaluating the effectiveness and safety of lorlatinib in patients with untreated ALK-positive non-small-cell lung carcinoma NSCLC in a real-world French context. This study, sponsored by Pfizer, focuses on adults aged 18 years and older who have locally advanced or metastatic ALK-positive NSCLC confirmed by specific diagnostic tests. The goal is to understand how lorlatinib works and its safety profile outside of controlled clinical trial settings. Participants in this study receive lorlatinib as a single agent at a dose of 100 mg taken orally once daily without interruption. The treatment continues as per routine care, and patients undergo thorough radiological evaluations including contrast-enhanced CT scans of the thorax and upper abdomen, as well as brain MRI, before starting lorlatinib. The study monitors various outcomes such as progression-free survival, overall survival, response rates, duration of response, and adverse events over a period of up to 48 months. Throughout the study, participants will have scheduled assessments at regular intervals including clinical evaluations, imaging studies, and questionnaires to track symptoms, treatment adherence, and quality of life. Researchers will also monitor for specific side effects, treatment resistance mechanisms, and changes in patient-reported outcomes related to central nervous system toxicity and overall health status. The total duration of participation includes follow-up visits lasting up to 48 months to gather long-term data on treatment effects and safety.

Researchers are investigating improved chemotherapy options for patients with metastatic Grade 3 poorly differentiated neuroendocrine carcinomas G3 NEC of the gastro-entero-pancreatic GEP system or unknown origin. These cancers are rare, often diagnosed at an advanced stage, and have limited treatment success with the current standard platinum-etoposide chemotherapy. The study aims to compare the mFOLFIRINOX regimen to the standard platinum-etoposide treatment and to explore molecular characteristics that might predict which patients respond best to each therapy. The trial compares two chemotherapy regimens mFOLFIRINOX, given every 14 days for up to 12 cycles, and platinum-etoposide, administered every 21 days for 6 to 8 cycles or up to 24 weeks. Both treatments are given intravenously on day 1 of each cycle, with continuation depending on disease progression and side effects. The mFOLFIRINOX regimen combines 5-fluorouracil, oxaliplatin, and irinotecan, while the platinum-etoposide regimen includes cisplatin or carboplatin plus etoposide. Molecular profiling of tumors will also be performed to identify biomarkers that may guide therapy choices. Participants will undergo regular scans and laboratory tests to monitor tumor response and side effects. Researchers will measure progression-free survival as the main outcome, along with overall survival, response rates, and treatment tolerability over up to 24 months. The study involves random assignment to one of the two treatment groups and requires ongoing monitoring to assess how well the therapies work and their safety in this patient population.

This research aims to improve genetic counseling by classifying gene variants found in families with a history of hereditary cancers, especially breast and ovarian cancer. Initially focused on BRCA1 and BRCA2 genes, the study now includes multiple genes from a large French oncogenetics database, covering thousands of families and variants. The goal is to better understand which gene variants are linked to cancer risk and to refine how these variants are classified for clinical use. Participants include index cases carrying specific gene variants and their family members. The study collects saliva samples from relatives to test for the presence of these variants, particularly those classified as uncertain significance class 3, likely pathogenic class 4, or hypomorphic pathogenic class 5. Genetic analyses are performed by specialized laboratories, and data from multiple families is combined to assess how these variants co-segregate with cancer occurrence. Throughout the study, researchers analyze genetic data using statistical models to estimate the likelihood that certain variants cause cancer. They use anonymous results for overall variant classification and share findings with families when variants are found to be pathogenic. This helps guide genetic counseling, possible preventive measures, and clinical management. The study spans up to 15 years and continuously updates classification methods and clinical recommendations based on new data.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

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 investigating the best length of prednisone treatment for patients with granulomatosis with polyangiitis GPA and microscopic polyangiitis MPA, serious autoimmune diseases that can relapse and cause damage despite current treatments. Rituximab is commonly used to maintain remission, but the ideal duration for prednisone therapy remains unclear. This trial is the first prospective study to compare longer versus shorter prednisone use as an add-on to remission maintenance in these conditions. Participants will receive either prednisone 5 mg per day or a placebo for 12 months, with dosing beginning on Day 1. Prednisone dosage will be tapered by 1 mg per week until complete withdrawal after 12 months. The study is randomized, double-blind, and placebo-controlled, evaluating the impact of extended prednisone use alongside rituximab maintenance therapy. During the 30-month study period, participants will be monitored for relapse-free survival, defined by a disease activity score BVAS greater than zero. Researchers will also assess serious adverse events, glucocorticoid-related complications like fractures and weight gain, vasculitis relapse rates, prednisone use, bone density, disease damage, functional disability, quality of life, and healthcare resource use. Assessments include clinical evaluations and standardized questionnaires to track disease status and treatment effects over time.

Researchers are studying genetic factors linked to early-onset cancer, focusing on patients with either inherited or spontaneous genetic alterations that may increase cancer risk. This study aims to evaluate a new genetic testing method called high-throughput exome sequencing SHD-E after standard gene panel tests fail to identify a genetic cause. The goal is to see if SHD-E can find additional genetic changes that contribute to cancer predisposition in patients diagnosed at a young age. Participants will undergo one genetic consultation and provide a blood sample for analysis. This approach is being assessed for patients diagnosed with cancer before age 40 or before age 30 for breast cancer who had negative results from routine gene panel tests. The study may also include tumor samples and, when necessary, testing of parents or affected relatives to support genetic analysis. During the study, participants will have their genetic mutations evaluated to identify new cancer risk factors. The study involves reviewing the genetic data collected from blood tests and possibly tumor samples. Participants must consent to join and be affiliated with a social security scheme. The primary outcome measured is the identification of genetic mutations that may explain cancer predisposition in these early-onset cases.

Researchers are evaluating three different approaches to improve cervical cancer screening participation among women aged 30 to 65 years living in two French departments. The study compares direct mailing of an HPV self-sampling kit, offering a choice between self-sampling or healthcare provider sampling, and the standard screening procedure. This randomized controlled trial aims to increase screening rates, assess feasibility, acceptability, and cost-effectiveness of these methods to inform the national screening program in France. Participants are randomly assigned to one of three groups the Outreach group receives a self-sampling kit directly by mail along with an SMS reminder if they do not participate within three months, plus assistance for follow-up cytology if HPV positive. The Choice group receives an invitation offering either to order a self-sampling kit or visit a healthcare provider, with reminders if they do not participate. The control group follows the standard invitation process with HPV self-sampling offered after a 12-month reminder if needed. Throughout the study, researchers will monitor participation rates at 18 months post-invitation, HPV positivity rates, completion of follow-up cytology, time to triage, and acceptability of self-sampling up to 24 months. Cost-effectiveness of each screening strategy will also be evaluated. Women will receive support for follow-up testing if needed, and reminders will encourage completion of screening steps. The total participation period lasts at least 24 months with ongoing data collection.

Bronchiectasis is a chronic lung disease involving permanent widening of parts of the airways, leading to mucus buildup, infections, and ongoing inflammation. Researchers are evaluating whether using the SIMEOX device at home, combined with remote physiotherapy, can improve quality of life and reduce lung flare-ups compared to enhanced standard care in patients with non-cystic fibrosis bronchiectasis. This study focuses on long-term effects over about two years. Participants will be randomly assigned to one of two groups one receiving standard care plus remote physiotherapy, and the other using the SIMEOX device daily at home along with remote physiotherapy and standard care. The SIMEOX device delivers short pulses of negative air pressure through a mouthpiece to help loosen and move mucus from the lungs. Remote physiotherapy sessions occur once a month for the first three months and then every three months thereafter. During the study, participants will be monitored for changes in quality of life using questionnaires at 6, 12, and 24 months, and the number of lung exacerbations over about 24 months will be recorded. Lung function tests spirometry will also be conducted periodically. Researchers will track treatment adherence, hospitalizations, and any adverse events. The total study duration per participant is around two years, with regular assessments to evaluate the impact of the SIMEOX device combined with physiotherapy.

This research aims to understand how neonatologists decide when extremely preterm infants, born before 28 weeks of gestational age, are ready to be taken off mechanical ventilation during the first two weeks of life. It focuses on the link between clinical assessments of extubation readiness and actual success, defined as no need for reintubation within seven days. The study also seeks to identify factors influencing these decisions and outcomes using both qualitative and quantitative data from several NICUs in France. The study involves no interventions or treatments but collects prospective information from attending physicians through questionnaires completed daily for the first 15 days of life while the infants are mechanically ventilated. Researchers will record reasons for extubation or non-extubation and monitor respiratory outcomes, including extubation failure rates and the duration of various types of respiratory support up to four months of age. Mortality and complications related to intubation will also be documented. Participants will be closely observed throughout their NICU stay, with data collected on respiratory status, mechanical ventilation duration, and clinical decisions regarding extubation. The primary outcome is the reasons for not extubating during the first 15 days of life, assessed multiple times daily early on and daily thereafter. Secondary outcomes include extubation readiness perceptions, extubation failure, bronchopulmonary dysplasia occurrence, length of NICU stay, and mortality up to five months of age. The study will conclude when patients are discharged or definitively weaned off respiratory support.