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. The study focuses on adults aged 18 years or older who have locally advanced or metastatic ALK-positive NSCLC confirmed by specific diagnostic methods. This non-interventional study aims to understand how lorlatinib performs outside of controlled clinical trial settings. Participants will receive lorlatinib as the treatment for ALK-positive NSCLC. Before starting treatment, patients must undergo a complete radiological assessment including contrast-enhanced CT scans of the thorax and upper abdomen and brain MRI, as per routine care. The study monitors patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, reflecting their ability to carry out daily activities. During the study, researchers will assess progression-free survival from the start of treatment up to 25 months. Patients will be followed through scheduled visits and examinations, including evaluations of clinical status and safety monitoring. Participants are expected to comply with the study protocol throughout the observation period, and data will be collected according to standard care practices in a real-world setting.

Researchers are evaluating the diagnostic use of two biomarkers, Glutathion S-Transferase-c0 (GST-c0) and Peroxyredoxin 1 (PRDX1), to identify patients who have experienced cerebral infarction (stroke) within a critical window of less than 4.5 hours. The study includes patients with neurological symptoms lasting less than 12 hours and aims to improve detection for timely treatment decisions, especially for those with unknown stroke onset times. Participants will have blood samples taken to measure GST-c0 and PRDX1 levels. These blood samples will be used for biological assessments and stored in a biobank. The study groups are defined by whether the blood sample is obtained within 4.5 hours or after 4.5 hours from stroke onset. Magnetic resonance imaging (MRI) must be performed within 30 minutes after blood collection to support diagnostic evaluation. During the study, participants will be evaluated for stroke symptoms and severity using the National Institute of Health Stroke Score. Researchers will collect detailed timing information about symptom onset and perform blood tests and MRI scans accordingly. The main outcomes measured are the time between stroke onset and blood sampling, assessing how well GST-c0 and PRDX1 levels identify strokes occurring within 4.5 hours. The study ensures participants are socially insured and monitors safety by excluding those with recent serious conditions or legal and psychiatric restrictions.

Researchers are investigating treatments for metastatic Grade 3 poorly differentiated neuroendocrine carcinomas (G3 NEC) of gastro-entero-pancreatic (GEP) origin or unknown primary. These rare cancers often have a poor prognosis and are usually diagnosed at an advanced stage. The current standard first-line chemotherapy is the platinum-etoposide regimen, which shows a response rate of 40 to 70% but limited progression-free survival and overall survival. This trial aims to evaluate whether a more personalized chemotherapy approach using the mFOLFIRINOX regimen could improve outcomes compared to the standard treatment, while also exploring molecular characteristics of tumors to identify predictive biomarkers for treatment efficacy. Participants will receive either the mFOLFIRINOX regimen, which includes 5-fluorouracil, oxaliplatin, and irinotecan, or the platinum-etoposide regimen. The platinum-etoposide treatment is given every 21 days for 6 to 8 cycles or up to 24 weeks, with specific dosing schedules for cisplatin or carboplatin and etoposide. The study investigates the potential benefits of the intensive mFOLFIRINOX regimen as a first-line therapy, considering its previous efficacy in other digestive cancers and manageable side effects administered on an outpatient basis. During the study, participants will be closely monitored with imaging scans such as CT or MRI to assess tumor response following RECIST 1.1 criteria. Blood tests will evaluate blood counts and liver function to ensure safety. Researchers will track progression-free survival as the primary outcome, with a median target of 7.5 months. Safety assessments and adherence to treatment protocols will be maintained throughout the trial. Participants must meet specific health and performance criteria and provide informed consent, with follow-up planned to evaluate treatment effects and identify molecular biomarkers related to therapy response.

Researchers are studying gene variants of uncertain significance (VUS) found in genes linked to hereditary breast, ovarian, and other cancers. The goal is to better classify these VUS using data from a large French genetic database to improve genetic counseling and help guide clinical decisions, including preventive surgeries. The study originally focused on BRCA1 and BRCA2 genes but now includes multiple cancer-related genes identified through ongoing genetic testing in French families. Participants include index cases who carry specific VUS classified as uncertain or likely causal, along with their selected family members. Saliva samples are collected from these relatives to test for the presence of the variants. The study uses co-segregation analysis, which examines how the variant tracks with disease within families, applying a Bayesian model alongside other genetic and clinical data to estimate the likelihood that a variant causes cancer. Participants provide informed consent and saliva samples for genetic testing. Researchers compile data from multiple families to strengthen the classification of variants. The primary outcome is to perform co-segregation analysis over a period of up to 15 years. This long-term study aims to refine the clinical relevance of genetic variants to support personalized cancer risk assessment and counseling for affected families.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

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 investigating the best length of prednisone treatment to prevent relapses in patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). These conditions can be controlled with immunosuppressive therapy, particularly with rituximab, but many patients experience recurring relapses that cause damage and require repeated treatments. While rituximab is used to maintain remission, the ideal duration of prednisone use remains unclear, with US studies favoring early withdrawal (6-12 months) and European studies supporting longer use (>18 months) due to lower relapse rates. Participants will be randomly assigned to receive either prednisone 5 mg/day orally for an additional 12 months with weekly tapering or a placebo after an initial tapering period. Both groups receive maintenance rituximab treatment. The study compares the effects of extended prednisone use versus early withdrawal on relapse rates to determine the best approach to maintenance therapy for these patients. During the study, participants will be monitored for relapse-free survival over 30 months, with relapse defined by a Birmingham Vasculitis Activity Score (BVAS) greater than zero. Researchers will track disease activity, medication adherence, and safety throughout the trial. The study includes assessments at screening and regular follow-up visits to evaluate the benefits and risks of prolonged prednisone treatment in combination with rituximab.

Post-partum depression is a depressive disorder that begins within the year after childbirth and affects about 16.7% of women in France. This condition can cause serious complications including risks to the mother and child, such as weakened bonding, altered parental behavior, and maternal suicide, which is a leading cause of maternal death in France. Despite these risks, many women with severe post-partum depression do not seek medical help due to fear of stigma and misunderstanding about the condition. This research evaluates access to screening for post-partum depression through a compulsory early postnatal interview introduced in July 2022, aiming to identify factors linked to referral by healthcare professionals. The study involves women who gave birth at the Centre Hospitalier de Troyes between July 2022 and October 2023. Participants receive information and a questionnaire to complete and return, focusing on whether they were referred by a professional during the early postnatal interview. Women taking part in the study will be assessed on their referral status by healthcare professionals three months after birth. Data collection includes questionnaires sent by mail. The study monitors referral rates and factors influencing access to screening, including economic and geographical aspects. Participation involves completing and returning the questionnaire, with the main outcome measuring referral during the early postnatal interview.

Researchers are investigating genetic factors that contribute to early-onset cancer, which can be inherited or occur sporadically soon after fertilization. This study aims to evaluate a new technique called high-throughput exome sequencing (SHD-E) to identify genetic predisposition to cancer in patients who had negative results from routine gene panel testing. This method may reveal alterations in genes not previously linked to cancer risk. Participants will provide blood samples for genetic testing using the SHD-E approach. The study focuses on patients diagnosed with cancer before age 40 (or before age 30 for breast cancer) who show no anomalies on standard gene panel tests. Both patients and, when applicable, their relatives or parents may be involved, especially if further trio analysis or functional studies are needed. During the study, participants will be assessed through blood tests and may provide tumor samples if required. Researchers will monitor genetic mutations linked to cancer predisposition. Participation involves signing informed consent and providing social security affiliation. Safety and eligibility will be carefully evaluated, including psychiatric status and pregnancy, to ensure appropriate involvement in this genetic study.

This research aims to improve participation in cervical cancer screening among women aged 30 to 65 years living in two French departments, Marne and Aube. Cervical cancer remains a significant health concern in France, with over 3,000 new cases and 1,100 deaths annually. Despite organized screening efforts, the national coverage rate falls below recommended targets. The trial compares three screening strategies: direct mailing of HPV self-sampling kits, offering a choice between self-sampling or healthcare provider sampling, and standard care. Participants are randomly assigned to one of three groups. The Outreach group receives an HPV self-sampling kit directly at home with an SMS reminder after three months if they do not participate, plus assistance for follow-up cytology if HPV positive. The Choice group can select either a self-sampling kit sent to their home or visit a healthcare provider, with a similar SMS reminder protocol. The control group follows usual screening procedures, including a self-sampling offer at 12 months if no participation is recorded. Women with positive HPV results are monitored for further cytology testing and receive tailored follow-up reminders. Women in the study complete screening through their assigned method, with participation tracked over 18 months after invitation. Researchers measure screening participation rates, completion of follow-up tests after positive HPV results, the practicality and acceptance of the strategies, and their cost-effectiveness. The findings could guide improvements to the national cervical cancer screening program to increase coverage and early detection.