Soyaux

Researchers are evaluating stereotactic radiotherapy to restore the effectiveness of anti-PD1 immunotherapy in patients with metastatic solid tumors who initially responded well to immunotherapy for more than six months but later experienced disease progression. The study focuses on the abscopal effect, where radiation to one tumor site may impact other untreated metastases. Participants will receive stereotactic radiotherapy in three sessions, each delivering 8 Gy of radiation lasting about 20 minutes, spaced 72 hours apart on Day 1, Day 4, and Day 7. This treatment is given alongside ongoing anti-PD1 immunotherapy. Prior to radiotherapy, a CT scan without contrast is performed to plan precise treatment. The radiotherapy device is used according to its approved medical indications. During the study, participants will be closely monitored with assessments up to 12 months after radiotherapy. Researchers will measure tumor response using iRECIST and RECIST 1.1 criteria on both irradiated and untreated lesions to evaluate the abscopal effect. They will also track progression-free survival, overall survival, adverse events, and timing of any new systemic treatments. The primary outcome is the objective response rate at 3 months post-radiotherapy in patients with confirmed progression after initial immunotherapy response.

Researchers are studying prostate cancer patients undergoing radical prostatectomy to compare three surgical methods robot-assisted laparoscopy, conventional laparoscopy, and laparotomy. The study aims to evaluate the impact of these techniques on urinary and erectile functions, as well as their cost-effectiveness and long-term outcomes. This large, multicenter prospective observational study responds to previous concerns about the lack of high-quality evidence for robot-assisted surgery in prostate cancer treatment. Participants will undergo one of the three prostatectomy procedures robot-assisted laparoscopy, conventional laparoscopy, or laparotomy. Urinary and erectile functions will be assessed before and after surgery using standardized scores like the EPIC 50 and the International Index of Erectile Function IIEF-5. Outcomes including urinary incontinence, erectile dysfunction, and prostate-specific antigen PSA levels will be followed for up to five years. Cost-effectiveness will be evaluated at 12 months using the EQ5d-5L score. Throughout the study, participants will be evaluated at multiple time points, including 45 days and up to five years after surgery, to monitor urinary and erectile functions and other prostatectomy-related effects. Assessments involve questionnaires and clinical measurements. This comprehensive follow-up is designed to help determine the benefits and risks of each surgical approach, supporting informed decisions for patients and healthcare authorities. The study excludes patients without French health insurance or those unable to consent, focusing on adult males scheduled for prostatectomy.

Researchers are evaluating the effectiveness of the Apneal4 app on smartphones for diagnosing sleep apnea syndrome SAS in adults who require polysomnography PSG as part of their routine care. The study aims to determine if Apneal4 can accurately classify SAS severity into four categories, estimate the Apnea-Hypopnea Index AHI, detect sleep stages, differentiate between central and obstructive apneas, and identify patient movements compared to PSG. Participants will wear a smartphone equipped with the Apneal4 app on their chest during a full night of sleep at home while undergoing polysomnographic recording. They will also complete several questionnaires assessing sleep symptoms and their experience with the Apneal4 app. The study will monitor these measures over an average of one year to evaluate device performance and patient acceptability. During the study, participants will be assessed using both the Apneal4 device and standard PSG. Researchers will compare Apneal4 results with screening questionnaires like NoSAS, Berlin, and Epworth. Participants will complete questionnaires about their sleep symptoms and the devices ease of use. The primary outcome is the performance of Apneal4 in diagnosing sleep apnea-hypopnea syndrome. Safety and feasibility will be monitored throughout the study, which is expected to last about one year per participant.

This clinical trial focuses on men with prostate cancer who are candidates for radical prostatectomy. It aims to compare outpatient versus inpatient robot-assisted radical prostatectomy to determine if managing the procedure as an outpatient leads to similar rates of early post-operative complications. The study evaluates early recovery outcomes and overall patient experience after surgery. Participants will undergo robot-assisted radical prostatectomy either as outpatients or inpatients. The trial compares these two approaches by monitoring early complications from the day of surgery up to eight days afterward. Additional outcomes evaluated include surgery duration, blood loss, recovery of urinary and erectile function, stress and anxiety levels around surgery, patient satisfaction, and longer-term follow-up for up to five years. During the study, participants will visit the clinic at 45 days, 6 months, and annually up to 5 years for check-ups and tests. They will complete surveys on urinary and erectile function, stress, anxiety, satisfaction, and quality of life for six months. Participants are also asked to keep diaries recording treatments and care procedures. Researchers will track hospital readmissions, complications, and economic and social costs related to patient care throughout the follow-up period.

This clinical trial investigates whether Resilience PRO, a digital tool for remote symptom monitoring, can improve the quality of life for adults diagnosed with cancer who are receiving systemic anticancer treatment. The study compares patients using Resilience PRO plus their usual care to those receiving usual care alone. Resilience PRO is approved by French health authorities and designed to collect patient-reported outcomes electronically. Participants in the intervention group will use the Resilience PRO mobile app, which regularly asks about symptoms and sends alerts to the care team when important symptoms are reported. This allows timely adjustment of care. Both the intervention and control groups will continue to receive their usual cancer treatment and care. The trial is randomized and open-label. Throughout the study, researchers will measure quality of life after 3 months as the primary outcome. They will also evaluate health economics over 12 months and overall survival over 36 months. Participants will be monitored remotely using the app, and the study will assess how symptom monitoring affects their care and well-being over time.