Beuvry

Swallowing disorders are common in intensive care unit ICU patients, especially those with tracheostomies that can cause changes affecting swallowing. These disorders are linked to serious problems like respiratory issues, poor nutrition, and even death. Current clinical exams lack precision, while existing tests like videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing FEES are invasive, resource-heavy, and hard to access. Researchers are exploring ultrasound imaging as a non-invasive and precise method to assess swallowing disorders in difficult-to-wean tracheostomised ICU patients. This observational study will enroll 119 difficult-to-wean tracheostomised patients over nineteen months at multiple hospitals. Each patient will undergo FEES and ultrasound evaluations within a two-hour window. Ultrasound will assess movements and structures including the tongue, larynx, and suprahyoid muscles. The ultrasonographer will be blinded to other assessments. The goal is to develop a diagnostic ultrasound model using selected variables, which will be transformed into an easy-to-use scoring system to predict swallowing disorders. Participants will be assessed through clinical data collection and swallowing tests. Ultrasound exams will measure features like tongue thickness and muscle contractions, while FEES will evaluate swallowing function and residue severity. Reliability tests will be done with multiple examiners. Researchers will analyze data statistically to create and validate the ultrasound scores accuracy and reliability. The study aims to improve early detection and management of swallowing disorders non-invasively, over the course of the study period ending in April 2026.

Researchers are conducting a Phase III international trial to study the effects and safety of androgen deprivation therapy ADT with or without darolutamide in men newly diagnosed with metastatic prostate cancer who have vulnerable functional abilities. This study specifically includes patients who have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The goal is to evaluate how these treatments impact disease progression and patient health over time. Participants will be randomly assigned to one of two groups one receiving ADT plus darolutamide 600 mg taken orally twice daily, and the other receiving ADT plus a placebo taken with the same schedule. Treatment will continue until imaging shows disease progression or until the patient or doctor decides to stop for reasons such as side effects or other health issues. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, further treatments, and any ongoing or new side effects. During the study, participants will undergo regular assessments including imaging scans to check for cancer progression, blood tests, evaluations of urinary symptoms, and quality of life questionnaires. Researchers will track outcomes like progression-free survival, overall survival, symptom changes, and adverse events. Monitoring visits will occur periodically both during treatment and follow-up to gather comprehensive data on health status and treatment effects.

Radiotherapy for breast cancer can cause arm lymphedema, which is swelling that may lead to long-term discomfort and affect quality of life. This clinical trial is designed to assess whether an artificial intelligence AI tool that predicts individual risk of arm lymphedema after radiotherapy can help patients and doctors make better treatment decisions. The trial includes women aged 18 or older with breast cancer needing regional lymph node radiotherapy after surgery, regardless of hormone receptor or tumor status. Participants will be randomly assigned to two groups. In the experimental group, patients and physicians will see the AI-predicted risk through a web app that explains risk factors and suggests measures like compression sleeves. In the control group, this risk information will not be shared. Both groups receive the same radiotherapy treatment they would normally have, with no changes to dose or technique. The AI tool is evaluated only for its impact on decision-making and outcomes. Throughout two years, participants will have regular check-ups to track treatment choices, side effects, shoulder movement, breast appearance, quality of life, and the accuracy of the AI tools predictions. Researchers will also monitor how well patients follow recommendations for using compression sleeves, as well as cancer recurrence and survival. Questionnaires and clinical exams will be conducted at baseline, during treatment, and at multiple follow-up points to gather detailed information.

Researchers are evaluating elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive ER and human epidermal growth factor receptor 2-negative HER2- breast cancer who have a relapse detected by circulating tumor DNA ctDNA. This international, multi-center, randomized, open-label phase III trial focuses on patients without distant metastasis who show ctDNA positivity during screening. The study aims to assess whether elacestrant can improve outcomes over the current standard endocrine treatments. The study consists of two phases. First, during the ctDNA screening phase, patients on standard adjuvant endocrine therapy will have plasma samples collected every six months for about 5.7 years to detect ctDNA. Patients who test positive will undergo imaging to confirm no distant metastasis and then be randomized 11 to either continue their current endocrine therapy or receive elacestrant 400 mg orally once daily. Treatment duration depends on prior endocrine therapy length, lasting between 2 to 6 years. Intensive follow-up with ctDNA testing and imaging occurs for up to 3 years after randomization. Participants will be monitored closely with blood tests for ctDNA at weeks 4, 16, and every 16 weeks thereafter, along with yearly mammograms, bone scans, and CT scans every 16 weeks to detect metastases or recurrences. Safety, quality of life, and overall survival are assessed throughout, with follow-up continuing until three years after the last patient enrolls. The primary outcome measured is distant metastasis-free survival at 6.25 years after the first randomization.

Researchers are evaluating the effects of American ginseng combined with vitamin C from Camu Camu berries on fatigue in patients treated for localized breast or gynecological cancer. This multicenter randomized trial aims to assess the safety and efficacy of the dietary supplement Qiseng in improving cancer-related fatigue. The study is randomized, double-blind, and placebo-controlled, led by the Centre Francois Baclesse. Participants receive either Qiseng, containing 200 mg of P. quinquefolius extract 30 mg ginsenosides plus 30 mg vitamin C, or a placebo made of microgranules without active extracts. Both groups take 2 capsules daily for 8 weeks. The trial includes detailed monitoring of fatigue and other quality-of-life aspects during and after treatment. During the study, participants will have their fatigue levels assessed after 1 week and 4 weeks following the 8-week treatment. Researchers will also evaluate other fatigue dimensions, treatment-related side effects, quality of life, anxiety, cognitive function, physical activity, sleep quality, and treatment acceptability at multiple timepoints. The study spans approximately 12 weeks with close follow-up for safety and outcome measurement.

Researchers are evaluating Tislelizumab as a first-line treatment for elderly patients aged 70 and above who have advanced esophageal squamous-cell carcinoma ESCC and are not eligible for platinum-based chemotherapy. This phase II, open-label study aims to assess the safety of Tislelizumab and its impact on overall survival at 6 months, considering PD-L1 protein expression on immune cells, along with other outcomes such as response rates, progression-free survival, quality of life, and immune biomarker prognostics. Participants will receive Tislelizumab, a monoclonal antibody targeting PD-1, administered by intravenous infusion at a dose of 200 mg every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity occurs, for a maximum duration of 2 years. Patients will be included regardless of PD-L1 status, with central comparisons made as part of ancillary analyses. During the study, participants will undergo regular assessments including imaging to evaluate tumor response, questionnaires to assess health-related quality of life, and geriatric evaluations. Safety will be monitored up to 90 days after the last dose. Researchers will measure overall survival at 6 months as the primary outcome, alongside secondary measures such as progression-free survival at 3 and 6 months, immune biomarker analysis, and comprehensive health evaluations throughout the treatment period and follow-up visits.

Squamous cell carcinoma of the anus is a rare but increasingly common cancer, often linked to human papillomavirus HPV. For early-stage tumors, combined radiotherapy and chemotherapy with 5FU and mitomycin-C provide good outcomes, but advanced tumors have a poor prognosis with a high relapse rate. Researchers are studying a new approach combining induction chemotherapy with docetaxel, cisplatin, and 5FU mDCF followed by standard chemoradiotherapy to improve treatment results for locally advanced anal cancer T3-4 or N1. This is a randomized phase 3 trial comparing this new strategy to the current standard treatment. The study includes two groups one receives the usual chemoradiotherapy, which involves 33 radiotherapy sessions over 6.5 weeks combined with mitomycin-C and capecitabine chemotherapy taken on radiotherapy days. The other group starts with 4 cycles of mDCF chemotherapy given every two weeks before receiving the same chemoradiotherapy as the control group. Radiotherapy uses intensity-modulated external irradiation with a targeted boost to the tumor and involved lymph nodes. Participants will be followed after treatment with check-ups at 8 weeks, then every 4 months for two years, and every 6 months in the third year. Follow-up includes clinical exams and imaging scans CT and MRI. The main measure of success is disease-related event-free survival two years after treatment. Other outcomes include overall survival, colostomy-free survival, treatment side effects, tumor response, and quality of life. The total study duration for each participant may extend over several years including this follow-up period.

Researchers are studying patients with metastatic colorectal cancer to identify clinical and biological factors that predict how well fruquintinib works in real-world settings. The study aims to confirm survival and safety results seen in previous trials and to better understand treatment outcomes, especially in older patients aged 70 and above, who have been underrepresented in earlier research. This cohort is designed to optimize treatment pathways by pinpointing patients who may benefit most from fruquintinib. Participants will receive fruquintinib, an oral drug that targets specific blood vessel growth receptors, given as 5 mg daily for 21 days followed by a 7-day break. This cycle repeats until the cancer progresses, unacceptable side effects occur, the patient dies, or the patient chooses to stop treatment. The study includes patients treated under compassionate use or after marketing authorization in France, integrating routine clinical practice data. During the study, participants will be monitored for overall survival up to one year after starting treatment, which is the main outcome measured. Additional monitoring includes progression-free survival within the same timeframe. The study involves collecting biological samples like circulating tumor DNA and tumor tissue blocks. Safety, survival, and treatment response data will be gathered to support understanding of fruquintinibs effects in everyday clinical use. The study is expected to continue until the end of 2031.

This research aims to observe patients in France with HER2-negative early breast cancer who are treated with olaparib, a medication chosen by their doctors. The study focuses on understanding how often patients complete the full course of olaparib treatment and gathers information on related genetic factors and medical history. It is a national, multicenter, prospective observational study without experimental treatment assignment. Participants in this study receive adjuvant olaparib treatment as part of their usual care under their physicians discretion. The study does not assign treatments but follows patients who start olaparib, tracking their treatment progress for up to 18 months after inclusion. There are no additional interventions or placebo groups. Throughout the study, researchers collect data on treatment completion rates, types of BRCA mutations, variant types, medical history, and the time until olaparib treatment stops. Participation involves observational follow-up, with no extra treatment visits beyond routine care. The overall participation lasts 18 months after a patients enrollment, focusing on real-world treatment experiences and outcomes.

Researchers are collecting detailed biological samples, imaging, environmental data, and patient-reported outcomes from cancer patients to support research aimed at understanding tumor biology and improving cancer care. This observational platform supports multiple projects focusing on different tumor types including thorax, head and neck, breast, gastrointestinal, genitourinary, central nervous system, and rare cancers. The goal is to enhance translational research, biomarker discovery, and clinical cancer study access. Participants provide tumor samples and clinical data which are analyzed using various genetic and molecular profiling techniques such as whole exome sequencing, RNA sequencing, and next-generation sequencing panels. Separate projects include studying young adults with rare cancers, molecular characterization of rare tumors, investigating molecular profiles in relation to environmental radon exposure, and assessing circulating tumor DNA as a marker for cancer recurrence. Participants are involved by providing biological material and clinical information, with data collected on tumor biology and treatment effects over five years. The study measures include understanding tumor biology, disease progression, treatment impact, biomarker identification, and matching patients to biomarker-driven clinical trials. Compliance with follow-up and consent are essential, and the study is designed to improve cancer patient care and research over an extended period.