Longjumeau

Researchers are conducting a French multicenter retrospective study to describe the clinical, histological, and radiological features of rare primary liver cancers. The study aims to collect biological tumor and blood samples and evaluate the effectiveness of treatments used in clinical practice to determine the best therapeutic sequences. This research will serve as the foundation for future translational studies to identify new molecular, histological, circulating, and radiological tumor biomarkers useful for diagnosis, prognosis, and treatment guidance. This study involves collecting data from patients diagnosed with rare liver cancers such as hepatocholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma, and hepatic angiosarcoma since January 1, 2018. Both living patients who agree to participate and deceased patients are included. Biological samples and tumor blocks are collected for analysis. Treatments received by patients in routine practice are reviewed to assess their efficacy and help define optimal treatment sequences. Participants provide consent for biological studies if living, and their medical records and tumor characteristics are reviewed. Researchers will describe the clinical, histological, and radiological tumor features and monitor outcomes up to five years from diagnosis. This detailed data collection supports long-term evaluation of rare liver cancers and aids in developing future biomarkers and therapeutic strategies.

This trial investigates the effect of bougie diameter size on the risk of staple-line leaks following laparoscopic sleeve gastrectomy (LSG), a common weight-loss surgery for people with morbid obesity. Staple-line leaks occur in about 3% of cases and can lead to serious complications and long recovery. The study compares the use of a standard bougie size (34, 36, or 38 French) versus a larger 48-Fr bougie to see if a bigger diameter reduces leak rates without affecting weight loss outcomes. Participants undergo LSG where a bougie is inserted through the mouth by the anesthesiologist to calibrate the size of the stomach remnant. The surgery is done alongside the bougie, with patients unaware of which bougie size is used. The study is randomized and prospective, focusing on comparing postoperative outcomes related to gastric leak and mid-term weight loss between the two bougie sizes. During the study, researchers monitor patients for 30 days after surgery to measure the rate of gastric leaks. Participants are followed to evaluate mid-term weight loss results. The study includes regular assessments and safety checks to track complications. This research aims to identify if using a larger bougie can lower leak risks while maintaining effective weight loss after LSG.

Researchers are evaluating the effectiveness of cotrimoxazole compared to the best standard antibiotic treatment for ventilator-associated pneumonia (VAP) caused by Enterobacteriaceae in adult patients admitted to intensive care units (ICU). This is a multicenter, randomized, non-inferiority Phase 3 trial aiming to show that cotrimoxazole is not worse than standard care in terms of patient survival 28 days after treatment begins. Participants must have a confirmed diagnosis of VAP with bacteria susceptible to cotrimoxazole. Patients are randomly assigned to receive either cotrimoxazole or the best standard antibiotic therapy, which may include beta-lactam or fluoroquinolone antibiotics. Treatment lasts for seven days, starting with an initial appropriate empiric antibiotic therapy. The dosing and administration of antibiotics are tailored according to current ICU guidelines. The trial is open-label due to variable antibiotic regimens in the control group. During the study, patients are closely monitored daily until death, ICU discharge, or 28 days after inclusion. Assessments include vital status, antibiotic use, new infections, and Clostridium difficile infections. Clinical signs and chest X-rays are reviewed on day 7 to evaluate cure. Weekly screenings for multidrug-resistant bacteria are performed until ICU discharge. The vital status is also checked at day 90, with follow-up contact for patients discharged before this time. An independent committee reviews the clinical and radiological outcomes without knowing the treatment assignments.

Researchers are studying patients who have metastatic lung cancer and have survived for more than three years after their diagnosis without receiving cytotoxic chemotherapy. The focus is on understanding their clinical features, health status, quality of life, and socio-economic impacts, including the effects of cancer treatments, the occurrence of new diseases, and return to work. This observational study aims to better identify the needs of these long-term survivors to improve their management. Participants will complete several questionnaires, including the Hospital Anxiety and Depression Scale (HAD), the Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13), and the Aix-Marseille-University (AMU) questionnaire. These are designed to assess anxiety, depression, lung cancer symptoms, treatment side effects, and overall quality of life. Questionnaires are completed at the start of the study, at 6 and 12 months, and then yearly for up to 5 years. Participants will be followed during their regular medical consultations as per usual care at participating centers. Throughout the study, researchers will collect information on clinical characteristics, treatment details, health status, socio-demographic factors, and quality of life measures. Data will be gathered at baseline and during follow-up visits up to 5 years. This information will help assess the long-term impact of lung cancer and its treatments on patients who are living well beyond initial expectations.

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.

Researchers are gathering real-world data on patients aged 70 years and older who are receiving first-line treatment for thoracic tumors, specifically Non-Small-Cell Lung Carcinoma (NSCLC). This Phase 4 study aims to characterize patients in terms of their geriatric, biological, and cancer-related features. It will also describe treatment methods by disease stage and evaluate outcomes related to treatment effectiveness, safety, and quality of life. Subgroups of patients treated with the same medication or innovative strategies will also be explored. Participants will receive systemic treatments that are authorized and available through standard care or compassionate use. Blood samples will be collected before starting treatment and stored in a biobank for up to 10 years. Quality of life will be assessed using specific questionnaires at various time points depending on disease stage and treatment type. Geriatric assessments including autonomy scales, cognitive tests, depression screening, fall history, and social environment evaluations will be performed. During the study, participants will follow their usual clinical care with regular visits, laboratory tests, imaging, and biopsies as needed to monitor their general health, treatment effectiveness, and side effects. They will complete quality of life questionnaires and undergo assessments tailored for older adults. Researchers will measure progression-free survival, defined as the time from first treatment dose until disease progression or death, with follow-up lasting up to two years.

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.

This research investigates the use of DDAVP to prevent rapid overcorrection of serum sodium levels in critically ill ICU patients with severe hyponatremia. The study focuses on patients with very low serum sodium (below 115 mmol/L) or slightly higher sodium (below 120 mmol/L) if they have neurological symptoms such as seizures or stupor. Participants are selected based on their fluid volume status and risk factors for brain complications, aiming to improve safety during sodium correction. Participants will be randomly assigned to receive either standard hyponatremia treatment alone or combined with DDAVP administered intravenously at 4 micrograms every 6 hours for up to 48 hours. Standard treatment includes sodium chloride 3% infusion for those with neurological symptoms or hypertonic/isotonic fluids for those without symptoms. The study is open-label due to the noticeable effects of DDAVP on urine output but maintains blinded evaluation of brain MRI scans to reduce bias. During the trial, patients will be closely monitored for changes in serum sodium concentration, urine output, and neurological status. The primary outcome is to reduce the occurrence of sodium overcorrection within the first 48 hours after randomization. Safety assessments include brain imaging and clinical evaluations. The study includes follow-up during treatment and aims to provide evidence on the best approach to safely manage severe hyponatremia in ICU settings.

Colorectal cancer is a common and deadly cancer in France, often spreading to the liver. About 30 to 60% of patients develop liver metastases, and only a small percentage can have these surgically removed right away. For those with tumors that cannot be surgically removed, treatments typically involve chemotherapy combined with targeted drugs like panitumumab or bevacizumab. This research investigates combining systemic chemotherapy with intra-arterial oxaliplatin to improve tumor response and survival in patients with liver-only metastatic colorectal cancer. The study compares intravenous oxaliplatin and intra-arterial oxaliplatin combined with LV5FU2 chemotherapy, with or without irinotecan and targeted therapies, as a first-line treatment. Oxaliplatin is given every 15 days either through a vein or directly into the liver artery. Other drugs include fluorouracil, folinic acid, panitumumab (for patients with specific genetic mutations), bevacizumab, and irinotecan. This treatment aims to improve response rates and reduce side effects compared to standard methods. Participants will undergo regular treatment cycles every 15 days and will be monitored for tumor progression over 24 months after randomization. Assessments include measuring tumor size and progression-free survival. Patients will also be closely monitored for side effects and treatment tolerance. The study aims to determine which treatment approach offers better control of liver metastases and longer survival for patients with colorectal cancer limited to the liver.