Aix En Provence

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the safety and effectiveness of brenipatide at different doses compared with a placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study focuses on participants who have a history of asthma requiring controller medication and recent severe asthma exacerbations. The goal is to better understand how brenipatide impacts asthma control over an extended period. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injection. The study includes a 52-week treatment period during which the effects of the drug on asthma exacerbations and symptoms will be monitored. This randomized, double-blind approach helps compare the responses between the treatment and placebo groups. Study involvement lasts about 65 weeks, covering screening, treatment, and follow-up phases. During the study, researchers will assess participants' asthma control using questionnaires and track the annual rate of asthma exacerbations. Safety and treatment responses will be closely monitored throughout the trial to evaluate the drug's impact and participant well-being.

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.

Psoriatic arthritis (PsA) is a type of arthritis that causes joint swelling and stiffness and is often seen in people with the skin condition psoriasis. It results from an overactive immune system attacking healthy tissue. This research aims to describe the long-term use and effectiveness of risankizumab (RZB) compared to other advanced treatments for managing PsA in everyday clinical care. The study is not conducted in the United States but will take place in about 15 countries and include between 900 and 1200 adult participants. Participants will be assigned in a 2 to 1 ratio to receive either risankizumab or other advanced therapeutic agents. The treatments will be given following usual medical guidelines, including approved dosing and indications, as determined by local regulations and professional standards. All study visits will occur during routine clinical care with no extra burden on participants. Participants will be followed and monitored for 24 months to observe treatment persistence. During the study, participants will continue their regular clinical visits without additional procedures or tests required by the study. Researchers will measure how many participants continue their prescribed treatment over the 24-month period. The study focuses on real-world treatment patterns and outcomes in patients with active PsA who have previously shown an inadequate response or intolerance to certain medications. Safety monitoring will align with routine clinical practice throughout the study duration.

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 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 investigating whether managing heart failure with optimal medical therapy alone is as effective as combining this therapy with Implantable Cardioverter Defibrillator (ICD) implantation in preventing sudden cardiac death. This trial focuses on patients aged 70 years and older who have an indication for ICD implantation for primary prevention of sudden cardiac death, regardless of whether they need cardiac resynchronization therapy. Currently, ICDs are used in elderly patients based on results from younger populations, but there is no direct evidence supporting their benefit in older adults, and avoiding ICD implantation could reduce complications and healthcare costs. The study is a randomized, open-label, multicenter trial comparing two groups: one receiving only heart failure optimal therapy (HFOT) and the other receiving HFOT plus ICD implantation. ICD implantation type and manufacturer are chosen by the local investigator. Patients in the HFOT alone group will not receive ICDs unless they develop sustained ventricular arrhythmias that warrant secondary prevention. A total of 730 patients will be enrolled over a period of four years, with follow-up continuing for four years after randomization. Participants will be monitored for overall survival up to 48 months after randomization. Assessments include heart function evaluation using echocardiography, single-photon emission computed tomography, radionuclide ventriculography, or cardiac magnetic resonance imaging conducted at inclusion or within the previous six weeks. The study will also track medical therapy optimization and any ICD-related events. Safety and survival data will be collected throughout the follow-up period to determine if heart failure optimal therapy alone is not inferior to combined treatment with ICD implantation.

This research focuses on men with benign prostatic hyperplasia (BPH), a condition causing urinary symptoms due to prostate enlargement. It evaluates whether a modified surgical technique that preserves ejaculation can provide similar relief of urinary symptoms as the conventional surgery, potentially improving quality of life by maintaining sexual function. The study is a multicenter, single-blinded, randomized clinical trial comparing two surgical methods for BPH treatment. Participants will undergo either partial trans urethral resection of the prostate, which preserves the prostatic apex to maintain ejaculation, or conventional complete endoscopic resection of the prostate. Both procedures aim to relieve urinary symptoms caused by BPH. The study compares the functional outcomes of these two surgeries, including urinary flow, ejaculatory function, sexual life quality, and surgery-related complications. During the study, men will be evaluated before surgery and followed for at least 6 months afterward. Assessments include the International Prostatic Symptom Score (IPSS) to measure urinary symptoms, ejaculatory function, sexual life quality, urinary flow rates, and monitoring for any complications or need for retreatment. The primary outcome is the IPSS score at 6 months post-surgery, helping to determine if the ejaculation-preserving technique is as effective as the conventional surgery for improving symptoms.

Researchers are evaluating the Coroflex4 ISAR NEO coronary stent system, a sirolimus-eluting stent, in patients with coronary artery disease and ischemic heart disease. This international, multicenter, prospective, non-randomized post-market clinical follow-up study aims to confirm and support the device's clinical safety and performance in a real-world, unselected patient population, following daily clinical practice. The study complies with the European Union Medical Device Regulation requirements for post-market clinical follow-up. The study involves patients who have been treated or planned to be treated with the Coroflex4 ISAR NEO coronary stent system as intended by the manufacturer. The device is used in patients undergoing percutaneous coronary intervention (PCI) following the latest European Society of Cardiology recommendations. Eligible patients have novel lesion lengths of 2-4 mm. The study collects data from consecutive patients treated with the stent to evaluate outcomes in routine clinical settings without randomization. Participants will be monitored for safety and efficacy outcomes, including freedom from target lesion failure within 7 days after treatment. The research team will follow patients' clinical status and device performance as part of standard care. Informed consent is required, and patients will be observed to confirm the stent's safety and effectiveness under everyday medical practice conditions. The study does not specify a maximum age limit and includes adult patients aged 18 and older.