Aix En Provence

Researchers are evaluating the efficacy and safety 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 progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the safety and effectiveness of brenipatide at different dose levels compared with placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study aims to better understand how brenipatide may affect asthma symptoms and exacerbations over one year of treatment. Participants in this study are adults aged 18 to 75 years with a history of asthma and recent severe exacerbations. Participants will be randomly assigned to receive either one of two doses of brenipatide or a placebo, all administered by subcutaneous injection. The treatment period lasts 52 weeks, during which participants receive their assigned injections and are monitored regularly. The study includes a screening period before treatment and a follow-up period after treatment to assess ongoing safety and effects. During the study, participants will attend visits to complete questionnaires, lung function tests such as forced expiratory volume in one second FEV1, and assessments of asthma control and medication use. Researchers will monitor asthma exacerbation rates, rescue medication use, and the presence of anti-drug antibodies. The total study duration including screening, treatment, and follow-up is approximately 65 weeks.

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.

Psoriatic arthritis PsA is a type of arthritis that causes joint swelling and stiffness, often occurring in people with the skin condition psoriasis. This study aims to understand how long patients continue treatment and how effective risankizumab RZB is compared to other advanced treatments for PsA in everyday clinical settings. The study will take place outside the United States across about 15 countries, involving between 900 and 1200 adult participants. Participants will receive either risankizumab or other biologic disease-modifying antirheumatic drugs bDMARDs as prescribed by their doctors following local guidelines. Treatments will be given as part of regular medical care without additional interventions from the study. Participants will be followed and observed for 24 months during their routine clinical visits. During the study, participants will attend their usual medical appointments where doctors will monitor their treatment persistence and response. The main outcome measured is how many participants continue their prescribed treatment up to 24 months. There is no expected extra burden or additional procedures for participants beyond their standard care.

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 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.

This research aims to evaluate the use of implantable cardioverter defibrillators ICD for preventing sudden cardiac death in patients aged 70 years and older who have an ICD indication for primary prevention. It specifically compares whether heart failure optimal therapy alone HFOT is not worse than combining HFOT with ICD implantation regarding overall survival at 48 months after randomization. The study addresses the lack of clear evidence about the benefit of ICDs in the elderly and seeks to understand if avoiding ICD implantation can reduce device-related complications and healthcare costs. Participants are randomly assigned to one of two groups one group receives heart failure optimal therapy without ICD implantation, and the other receives optimal medical therapy plus ICD implantation. ICD devices used are any CE-marked brand available and reimbursed in the French market, implanted at the discretion of the local investigator. The study follows patients for four years after randomization, monitoring survival and health outcomes. During the study, participants undergo regular assessments including heart failure evaluations and quality of life questionnaires at multiple intervals up to 48 months. Researchers measure overall survival as the primary outcome and track cardiovascular mortality, sudden cardiac death, hospitalizations, ICD-related complications, and quality of life scores as secondary outcomes. The trial includes follow-up visits to monitor health status, treatment adherence, and complications to provide comprehensive data on the long-term impact of these treatment strategies.

This research aims to collect real-life clinical data to evaluate the safety and performance of medical devices used in treating prostate cancer. Specifically, it focuses on patients who have received High Intensity Focused Ultrasound HIFU treatment using the Focal One device. The study is both prospective and retrospective, gathering information over several years to better understand treatment outcomes. Participants are men treated for prostate cancer with the Focal One HIFU device. The study involves monitoring from the time of HIFU treatment up to five years afterward. Throughout this period, data will be collected on prostate-specific antigen PSA levels, prostate MRI findings for local cancer recurrence, biopsy results, and any retreatment rates to assess ongoing treatment safety and effectiveness. Participants will contribute data over a follow-up period extending up to five years after their HIFU treatment. Researchers will collect and review clinical information, imaging results, and laboratory tests. The primary focus is on monitoring safety outcomes related to the HIFU procedure. This long-term observation aims to provide a comprehensive understanding of treatment effects and patient health over time.

Researchers are studying men over 40 years old with benign prostatic hyperplasia BPH who need surgery to improve urinary symptoms. The trial compares two types of prostate surgery a conventional endoscopic resection and a newer partial surgery that aims to preserve ejaculation function. This study explores whether the partial surgery can maintain ejaculation without reducing the relief of urinary symptoms, which is important because ejaculatory dysfunction often lowers quality of life after surgery. Participants are randomly assigned to one of two surgical groups. One group undergoes conventional endoscopic resection of the prostate, while the other receives a partial endoscopic resection that preserves the apex area near the veru montanum. The study is single-blinded, meaning patients do not know which surgery they receive. The main focus is on symptom improvement measured by the International Prostatic Symptom Score IPSS six months after surgery. During the study, men will have evaluations at 1, 3, 6, 12, and 36 months after surgery. These assessments include urinary symptoms, ejaculation and overall sexual life, urinary flow rates, and any surgery-related complications. The trial tracks these outcomes to understand the benefits and effects of each surgical method over time. Patients are expected to comply with scheduled visits and provide informed consent before participating.