Sens

Researchers are monitoring the use of the Virtue4 Male Sling System in men with stress urinary incontinence following prostate surgery. This observational study aims to collect medical data on the devices effectiveness and safety over 12 and 36 months after implantation. The study is conducted in multiple centers across Europe and focuses on real-world use by experienced urologists. The Virtue4 Male Sling is an implantable device made of polypropylene mesh designed to support the urethra and help manage urinary incontinence caused by intrinsic sphincter deficiency. This study involves men who have already received the sling during routine clinical care. Follow-up includes visits at baseline before implantation, between 1 and 3 months post-operation, and at 12 months, with additional annual questionnaires sent out at 24 and 36 months. Participants will undergo routine clinical assessments, including questionnaires about their urinary symptoms and quality of life, pad weight testing, uroflowmetry, and measurement of urine remaining after voiding at several points during the study. Researchers will monitor patient-reported improvement and any adverse events at 12 months. The study extends to 36 months with ongoing questionnaires to track long-term outcomes and satisfaction. Participation involves regular clinical visits and mailed surveys over three years.

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.

This trial investigates the effectiveness of tepotinib compared to standard treatments in patients with advanced non-small cell lung cancer NSCLC who have a specific MET exon 14 mutation and have progressed after at least one prior treatment. The study addresses the lack of comparative data for new-generation MET tyrosine kinase inhibitors TKIs in this patient group and aims to generate evidence to support reimbursement and access to tepotinib in France. Tepotinib is seen as a promising oral treatment option for typically elderly and frail patients with limited therapeutic choices. Participants will be randomly assigned to receive either tepotinib orally once daily at 500 mg or an investigator-chosen standard treatment, which may include various chemotherapy drugs, anti-PDL1 agents, or best supportive care for certain patients. Treatments in the control group cannot have been previously received by the patient. This study includes crossover to tepotinib for patients in the control arm who experience disease progression. The trial duration for primary outcome assessment is about 36 months. Throughout the study, patients will undergo regular assessments including scans and laboratory tests to monitor disease progression and treatment safety. Quality of life, objective response rate, duration of response, and treatment adherence are among the measured outcomes. Safety and tolerability of treatments will also be evaluated. This trial is expected to last until mid-2028, with close monitoring to ensure patient well-being and gather comprehensive data on treatment effects.

Researchers are studying advanced cancer of the stomach and the gastro-esophageal junction, a serious disease with low survival rates. The trial focuses on patients whose cancer has progressed after two or three prior treatments. The study aims to evaluate whether combining the oral drug trifluridinetipiracil with the anti-angiogenic drug fruquintinib can improve survival compared to trifluridinetipiracil alone. This international Phase III trial builds on recent advances in immunotherapy and targeted therapies for this cancer type. Participants are randomly assigned to one of two groups. One group receives trifluridinetipiracil alone in 28-day cycles, taking the drug by mouth twice daily on Days 1 to 5 and Days 8 to 12 with rest days in between, repeated every 4 weeks. The other group receives the same trifluridinetipiracil schedule plus fruquintinib by mouth once daily for 21 days each cycle. Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant chooses to stop. During the study, participants undergo regular assessments to monitor overall survival up to 18 months after starting treatment. Researchers will also measure progression-free survival during this period. Patients will have tumor evaluations, laboratory tests, and monitoring for treatment side effects. Participants must meet specific health criteria and agree to biological studies. The study provides close follow-up to evaluate the effects of the treatments over time.