Beuvry

Swallowing disorders are common in patients who have difficulty being weaned from mechanical ventilation in intensive care units, especially those with tracheostomies. These disorders can lead to serious complications such as respiratory problems, nutritional issues, and even death. Current clinical examinations for swallowing disorders lack precision, and complementary tests like videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing (FEES) are invasive, resource-intensive, and not easily accessible. Ultrasound imaging offers a promising, non-invasive alternative that can provide both qualitative and quantitative assessments of swallowing-related structures to improve diagnosis and rehabilitation targeting. This research aims to develop and evaluate a new ultrasound-based diagnostic model for detecting swallowing disorders in difficult-to-wean tracheostomised patients. Over a nineteen-month period, 119 eligible patients will be enrolled from multiple hospitals. Each participant will undergo a FEES evaluation and an ultrasound exam focusing on tongue movement, laryngeal motion, and suprahyoid muscles. Ultrasound assessments will be conducted with the operator blinded to other clinical data. The study will develop a predictive model using logistic regression and transform it into a practical scoring system to aid diagnosis. Participants will be assessed within a two-hour timeframe using FEES and ultrasound. Data collection includes demographic, medical history, and ultrasound measurements such as muscle thickness, movement, and echointensity. Reliability will be tested with repeated exams by different operators. The primary outcome is developing a swallowing disorder prediction model. Researchers will analyze the model’s sensitivity, specificity, and predictive value. Safety and validity will be closely monitored, and the study will provide a non-invasive tool to enhance early detection and personalized management of swallowing disorders in this patient population.

Researchers are conducting a Phase III, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of androgen deprivation therapy (ADT) with or without darolutamide in men with newly diagnosed metastatic prostate cancer who have vulnerable functional ability. These patients have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 participants who meet specific frailty and disease criteria. Participants will be randomly assigned to one of two groups: the experimental group will receive ADT plus darolutamide 600 mg taken orally twice daily, and the control group will receive ADT plus a placebo taken orally twice daily. Treatment will continue until there is evidence of disease progression on radiographic scans or if the patient or investigator decides to stop treatment for reasons such as side effects or other health conditions. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, additional cancer treatments, and any ongoing or new side effects. During the study, patients will undergo assessments according to established prostate cancer clinical trial criteria to evaluate their response to treatment. Researchers will monitor the time until disease progression or death for up to 18 months as the main outcome. Safety and treatment effects will be tracked through scheduled visits, laboratory tests, and imaging. The long-term follow-up will help understand survival outcomes and the impact of subsequent treatments over many years.

Radiotherapy after breast cancer surgery can cause arm lymphedema, which is swelling that may lead to long-term discomfort and impact quality of life. This research aims to evaluate whether using an artificial intelligence (AI) tool to predict each patient's risk of developing arm lymphedema can help patients and doctors make better treatment decisions. The study involves women aged 18 years or older with unilateral breast cancer who need regional lymph node irradiation after surgery, regardless of hormone receptor status or tumor grade. Participants will be randomly assigned to two groups. In the experimental group, patients and physicians will see the AI-predicted risk of developing arm lymphedema and use this information to guide treatment choices. In the control group, the risk prediction will not be shared. All participants will receive radiotherapy as they normally would, and the only difference is whether they are informed about their predicted risk using the XAINET AI tool presented via a web app. During the two-year follow-up, researchers will monitor how sharing risk information affects treatment decisions, the occurrence of side effects like arm lymphedema, the accuracy of the AI tool, patients' quality of life, and adherence to wearing compression sleeves. They will also track cancer recurrence and survival outcomes. Patients will have scheduled visits and assessments to collect this information throughout the study.

Researchers are conducting a multicenter prospective study to identify microbiome-based biomarkers in patients with cancer. This study focuses on collecting biological samples to understand the relationship between the microbiome and cancer treatment outcomes. Participants will provide stool and blood samples multiple times during the study. Samples are collected at baseline or before the third treatment injection, at the first evaluation with CT-scan, at six months or more after the first injection, during any toxicity events, at relapse, and one week after completing antibiotics treatment. Throughout the study, participants will undergo these sample collections at specified time points to monitor changes in their microbiome. The main outcome being measured is overall survival up to two years. Patients will provide informed consent and cooperate with study procedures while being followed for the duration of their cancer treatment and monitoring.

Researchers are investigating the use of 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 aims to determine if elacestrant offers a benefit over current endocrine treatments in this group of patients without distant metastases. The study includes a lengthy ctDNA screening phase to identify eligible participants and monitor their disease status over time. The study begins with a ctDNA screening phase, where patients receive standard adjuvant endocrine therapy such as tamoxifen, letrozole, anastrozole, or exemestane, and have blood collected every six months for ctDNA testing until about 5.7 years after enrollment ends. Those who test positive for ctDNA and show no distant metastasis on imaging will be randomized within four weeks to continue their current endocrine therapy or switch to elacestrant taken orally at 400 mg daily. Treatment duration varies based on prior endocrine therapy exposure, ranging from two to seven years. After treatment, further care is at the physician's discretion. Participants will have frequent follow-up visits with ctDNA testing at weeks 4 and 16 post-randomization and every 16 weeks thereafter for up to three years. Imaging studies including mammograms, bone scans, and CT scans will be conducted regularly to monitor for distant metastases or new cancers. The main outcome measured is distant metastasis-free survival, assessed up to 6.25 years following the first patient enrollment. The study ends when all patients complete their visits or discontinue for reasons such as withdrawal, loss to follow-up, or death, and data is fully analyzed and finalized.

Researchers are evaluating the effects of Qiseng®, a dietary supplement made from American ginseng extract combined with vitamin C from Camu Camu berries, on fatigue in female patients treated for localized breast or gynecological cancer. This multicenter randomized, placebo-controlled, double-blind trial aims to assess the safety and effectiveness of Qiseng® in reducing cancer-related fatigue experienced after treatment. Participants will be randomly assigned to receive either Qiseng® or a placebo, each given as two capsules daily for 8 weeks. The study involves a comparison between these two groups to monitor changes in fatigue levels over the treatment period. During the trial, researchers will assess participants' fatigue scores using a visual scale at one week and four weeks after finishing the 8-week treatment. Participants will be monitored for safety and adherence throughout the study, which includes follow-up assessments to measure the change in fatigue associated with the intervention.

Researchers are investigating the safety and effectiveness of Tislelizumab, a monoclonal antibody, as a first treatment option in elderly patients aged 70 years or older with advanced esophageal squamous-cell carcinoma (ESCC) who are not eligible for platinum-based chemotherapy. This phase II, multicenter, open-label study aims to assess survival rates at 6 months, overall response rates, progression-free survival at 3 and 6 months, and quality of life. The study also explores the impact of PD-L1 expression on treatment outcomes and the role of immune biomarkers and geriatric factors in prognosis. Participants will receive Tislelizumab intravenously at a fixed dose of 200 mg every three weeks for up to two years or until disease progression or unacceptable side effects occur. The study includes patients regardless of their PD-L1 status, with central analysis of this protein as part of additional investigations. This trial is the first to evaluate the use of an anti-PD-1 immune checkpoint inhibitor alone in elderly ESCC patients who cannot undergo chemotherapy with platinum drugs. During the study, participants will undergo regular assessments including imaging tests to evaluate tumor response, laboratory tests to monitor organ function, and questionnaires to assess health-related quality of life. Researchers will track overall survival and progression-free survival, monitor safety and side effects, and observe immune and geriatric parameters. The main outcome is the percentage of patients alive at 6 months after starting treatment, with ongoing follow-up to evaluate other measures and biomarkers over the study period.

Researchers are investigating treatments for locally advanced anal squamous cell carcinoma, a rare but increasing cancer often linked to human papillomavirus (HPV). The study compares standard chemoradiotherapy, which combines radiation and chemotherapy with 5FU and mitomycin-C, to a new approach adding induction chemotherapy (modified DCF protocol) before the standard chemoradiotherapy. This randomized phase 3 trial aims to improve disease-related event-free survival and other outcomes such as overall survival, colostomy-free survival, treatment tolerability, response rate, and quality of life in patients with T3-T4 or N1 stage anal cancer without metastasis. Participants in the experimental group receive four cycles of induction chemotherapy (docetaxel, cisplatin, and 5-FU given every two weeks), followed by standard chemoradiotherapy consisting of 33 sessions of radiation over 6.5 weeks combined with mitomycin during weeks 1 and 5 and capecitabine taken on radiation days. The control group receives only the standard chemoradiotherapy. Radiation is delivered using intensity-modulated external irradiation (IMRT-SIB) targeting the pelvis and tumor area with specified doses. During the study, patients undergo follow-up visits starting 8 weeks after treatment, then every 4 months for two years, and every 6 months for a final year. Follow-up includes clinical exams and imaging tests such as CT and MRI. The study measures disease-related event-free survival at 2 years after treatment completion as the primary outcome. Participants must be adults aged 18 or older with measurable tumors on MRI and able to receive chemotherapy and radiotherapy, with additional health criteria assessed before enrollment.

This research aims to observe patients in France who have HER2-negative early breast cancer and are treated with olaparib. The study focuses on understanding how many patients complete the full planned course of olaparib treatment, which is given as adjuvant therapy following initial cancer treatment. It is a national, multicenter, prospective cohort study conducted without altering the usual care provided by doctors. Patients enrolled will be those starting adjuvant olaparib treatment based on their doctor's decision. There are no experimental interventions or treatment changes imposed by the study. The study captures real-world use of olaparib across multiple centers in France. Participants will be followed for at least 18 months after joining the study to see if they complete the full duration of olaparib treatment. Researchers will collect data on treatment adherence and other relevant clinical information during this period. The main outcome measured is the proportion of patients who receive olaparib for the entire planned treatment period.

Researchers are collecting detailed clinical and biological data from cancer patients with various tumor types to support advanced translational and clinical cancer research. This platform, called SPECTA, gathers annotated biological samples, imaging data, operative images, environmental assessments, questionnaires, and patient-reported outcomes to improve understanding of tumor biology and patient care over a 5-year period. Participants provide biological materials such as tissue samples that undergo genetic analyses including whole exome sequencing, RNA sequencing, and various genetic panels across multiple research projects within the platform. These analyses support biomarker discovery and other research aims. The platform integrates data collection from several downstream projects using advanced genetic and molecular techniques. During the study, patients are followed with assessments that include collection and confirmation of adequate biological material, clinical data, and patient questionnaires. Researchers monitor quality assurance and compliance with study protocols. The primary outcome focuses on establishing a reliable platform to enhance cancer research and improve patient care over five years.