Saint Jean De Luz

Researchers are evaluating new drugs and drug combinations to treat relapsed or refractory peripheral T-cell lymphomas through a platform trial consisting of multiple sub-studies. The study aims to gather early data on these treatments to better identify which patient groups may benefit and to guide future clinical trials. Phase 1 sub-studies focus on determining safe dosage levels, while phase 2 sub-studies aim to find drugs that significantly improve treatment outcomes. Secondary goals include assessing response rates, clinical benefits, progression-free survival, overall survival, and safety profiles of the drugs used. The trial includes several sub-studies with distinct treatments. The Origina-ly-T sub-study is an open-label phase 2 trial studying the safety and effectiveness of roginolisib, given daily until unacceptable side effects, disease progression, or withdrawal. The GolcAza sub-study is an open-label phase 1 trial evaluating the maximum tolerated dose of golcadomide combined with oral 5-azacitidine for follicular helper T-cell lymphoma. Participants receive these drugs daily until the study ends, disease worsens, or withdrawal occurs. During the study, participants will attend scheduled visits for evaluations including scans, laboratory tests, and assessments of treatment response and side effects. Researchers will monitor progression-free survival and determine the maximum tolerated and recommended doses in the sub-studies. The total participation time may last up to two years from enrollment, with ongoing safety and effectiveness monitoring throughout that period.

Researchers are evaluating the SING IMT12 prosthesis in patients aged 55 and older who have late-stage Age-Related Macular Degeneration (AMD) with bilateral central vision impairment and have previously undergone cataract surgery with intraocular lens (IOL) implantation. This international, randomized, multicenter study aims to assess the safety and effectiveness of the device in pseudophakic patients. The findings will support regulatory decisions, clinical guidance, and possible expansion of the device's approved use. Participants will be randomly assigned to one of two procedures: either the existing IOL will be removed and replaced with the SING IMT12 device implanted in the sulcus (Lens-Exchange group), or the SING IMT12 device will be implanted in front of the existing IOL in the sulcus (Add-on group). Both procedures involve surgical implantation of the device designed to improve vision in this patient group. During the study, participants will be monitored for endothelial cell density (ECD) loss at baseline, and then at 1, 3, and 6 months after surgery. Assessments will include vision tests, evaluation of peripheral vision, and follow-up visits to monitor safety and device performance. Participants will also take part in a postoperative training program to learn how to use the SING IMT12 implant effectively. Total study duration and detailed follow-up procedures will support thorough evaluation of treatment outcomes and safety.

Researchers are evaluating the safety and effectiveness of the SING IMT (Smaller Incision New Generation Implantable Miniature Telescope) 3X implant in improving vision for patients aged 55 and older with central vision impairment caused by end-stage Age-related Macular Degeneration (AMD). This is a prospective, multicenter, open-label study focusing on patients who have significant vision loss and cataracts, aiming to assess how well the implant works in real-world settings over a year. Participants who qualify will undergo outpatient surgery to receive the SING IMT 3X device during routine cataract surgery. Before surgery, patients are tested using a 2.8X external telescope simulator to ensure they can benefit from the implant. After implantation, they will attend 6 to 10 vision training sessions with a low vision specialist to help adjust to the device. Surgeons will also complete satisfaction surveys after each implant procedure. Throughout the 12-month follow-up, patients will have regular eye exams to monitor their vision in both eyes, track any surgical complications, and report any adverse events or medication use. The study team will closely observe safety outcomes related to the implant and how it affects the patients’ visual acuity and daily functioning during these visits.

Colorectal cancer mainly affects elderly patients, with over half of new cases in France occurring in those aged 70 or older. Adjuvant chemotherapy has shown benefits in disease-free and overall survival after stage III colon cancer surgery, but its use in elderly patients remains limited. This phase III randomized study explores whether adjuvant chemotherapy improves disease-free survival in elderly patients and which chemotherapy regimen is most effective, addressing concerns about benefits for both unfit and fit elderly patients. Participants will be divided into two groups based on a multidisciplinary evaluation including a geriatrician. One group will receive fluoropyrimidine-based chemotherapy (LV5FU2 or capecitabine), and the other will receive oxaliplatin-based chemotherapy (FOLFOX4 or XELOX). Some patients may be assigned to observation only. Treatments will begin within 12 weeks after surgery. The study also evaluates specific biological markers common in elderly tumors, such as mismatch repair deficiency. During the study, participants will undergo assessments including geriatric questionnaires and medical monitoring. Researchers will track disease-free survival over three years following the last patient's enrollment. Safety and treatment effects will be monitored, with exclusion of patients expected to live less than four years or those unable to comply with follow-up. The study aims to better understand chemotherapy benefits in an elderly population after colon cancer surgery.

Researchers are evaluating the safety and effectiveness of a new surgical technique called Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) compared with the traditional Anterior Cervical thyroidectomy (AC) for patients needing lobectomy or total thyroidectomy. The study focuses on patients with thyroid nodules suspected of malignancy and thyroid volumes under 60 mL. TOETVA is an innovative approach that avoids visible neck scars by accessing the thyroid through the mouth, offering potential benefits in appearance and recovery. This technique is more technically demanding and requires careful evaluation to ensure it is as safe as the standard AC approach. Participants will be randomly assigned to receive either the TOETVA procedure or the traditional AC surgery. TOETVA uses endoscopic tools inserted through the mouth to reach the thyroid gland with less external dissection, while AC involves an incision in the front of the neck. Both procedures aim to remove part or all of the thyroid gland. The study will monitor early postoperative complications within the first 24 hours after surgery to compare safety between the two methods. During the study, participants will undergo thorough evaluations including endocrinological assessments before surgery. Researchers will measure outcomes such as complication rates, pain levels, quality of life, and the impact of visible scarring using validated questionnaires. Patients will be followed closely postoperatively to assess recovery and any complications. Participation requires an informed consent process and affiliation with a healthcare insurance plan. The study includes adult patients aged 18 to 65 years who are candidates for thyroid surgery without additional lymph node procedures.