Bourgoin Jallieu

Researchers are evaluating the effectiveness of different antimicrobial treatments for infections caused by difficult-to-treat Pseudomonas aeruginosa bacteria. This infection is especially challenging for patients who are critically ill or have weakened immune systems. The study focuses on comparing new beta-lactam/beta-lactamase inhibitor combinations, cefiderocol, and older drugs like aminoglycosides and colistin in real-life clinical settings across multiple hospital centers in France. Participants will receive intravenous antimicrobial therapy tailored to treat their difficult-to-treat P. aeruginosa infection. The study observes the use of new and older antimicrobial drugs to assess their clinical efficacy. Patient data and bacterial samples will be collected and analyzed centrally to better understand drug resistance mechanisms and treatment outcomes. Participants will be monitored for clinical cure shortly after completing therapy and on Day 7 ± 2 days. Researchers will collect clinical information through electronic case-report forms and send bacterial isolates to a national center for detailed testing. Outcomes include cure rates, resistance development, adverse events, and mortality rates, with follow-up during hospitalization and up to 28 days after treatment. The study aims to provide valuable real-world data on treating these challenging infections.

Primary Sjf6gren's syndrome (pSS) is a chronic autoimmune condition that can affect multiple organs, lower quality of life, and sometimes cause serious health problems. This research aims to evaluate whether the presence of a specific antibody, anti-Ro/SSA IgE, is higher in patients experiencing active disease, as measured by a standardized disease activity index. The study focuses on patients newly diagnosed or previously diagnosed with pSS to explore this antibody's potential as a biomarker for disease activity. Participants will have blood samples collected at the start of the study to measure anti-Ro/SSA IgE levels using an enzyme-linked immunosorbent assay (ELISA). Alongside this, clinical data including the EULAR Sjf6gren Syndrome Disease Activity Index and Patient Reported Index will be gathered to assess disease features and activity. No other treatments or interventions are described, and the study appears observational focusing on biomarker evaluation. During the study, participants will undergo blood sampling at inclusion to determine antibody levels and have their disease activity recorded through questionnaires and clinical assessments. The main outcome measured is the proportion of patients who test positive for anti-Ro/SSA IgE at the start of the study. This information will help researchers understand the relationship between this antibody and active pSS, potentially aiding future patient monitoring. The study includes follow-up examinations as required, with safety and disease activity monitored throughout participation.

Colorectal cancer is one of the most commonly diagnosed cancers worldwide and especially in France. Anastomotic leak, a serious complication after colorectal surgery, affects at least 7% of patients undergoing left colonic cancer surgery. This trial evaluates the use of intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG) to reduce the risk of anastomotic leakage after surgery for left-sided or high rectal colorectal cancer. The FLUOCOL-1 study is a national, multicenter, single-blind, randomized phase III trial aiming to show whether IOFA with ICG lowers the rate of leaks within 90 days after surgery. Participants will be randomly assigned to either the IOFA group, where an intravenous bolus of indocyanine green is injected during surgery and fluorescence is detected with a near-infrared camera, or to the control group receiving standard surgery without IOFA. The study involves adult patients scheduled for elective left colectomy or high rectal resection with intraperitoneal anastomosis, performed by open, laparoscopic, or robotic methods. Surgeons may perform an additional dye injection if needed. The trial will run across 26 centers with 1010 patients over 36 months. Patients will be followed for 90 days with visits before surgery, and at 30 and 90 days after surgery, aligning with routine care schedules. Data collected include clinical outcomes, imaging, and patient-reported quality of life questionnaires. The primary outcome is the occurrence of anastomotic leakage within 90 days post-operation. Safety and effectiveness will be monitored, with an interim analysis planned after half of the patients are enrolled. Positive results may establish IOFA as a standard practice to reduce complications and improve recovery after colorectal surgery.

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 studying lymphoma using the REALYSA cohort, a real-life, population-based platform in France that combines epidemiological, clinical, and biological data. This approach aims to improve understanding of the factors influencing treatment resistance and relapse in lymphoma patients, monitor long-term effects and quality of life, and record the effectiveness and adherence to treatments in everyday medical practice. The platform also addresses socioeconomic questions related to lymphoma care. The study involves collecting detailed data on patients diagnosed with one of seven specific lymphoma subtypes, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, T-cell lymphoma, Hodgkin's lymphoma, and Burkitt lymphoma. Data collection will include patient numbers by subtype and region. This observational platform does not involve experimental treatments but focuses on real-world data gathering and analysis. Participants will be followed over time to monitor progression-free survival for up to five years. Researchers will gather clinical, biological, and epidemiological information and track patients' health status and treatment outcomes. The study includes regular assessments to better understand lymphoma progression, treatment effects, and patient quality of life in a real-life setting. The total involvement duration depends on patient follow-up over several years.

Researchers are investigating how the body processes and responds to the drug venetoclax in patients diagnosed with Acute Myeloid Leukemia (AML). This prospective, multicenter cohort study focuses on understanding the pharmacokinetics and pharmacodynamics (PK-PD) of venetoclax to better assess its behavior and effects in these patients. The study intends to include 100 patients over a 12-month period, aiming to gather detailed biological and clinical data without altering the patients' usual treatment plans. Participants will undergo blood sampling to measure venetoclax levels at various points during their treatment period. Up to 21 samples may be collected, with a maximum total of 12 mL of blood drawn per sampling day, divided into three samples of 4 mL each. These samples will be used for pharmacokinetic dosing to track the drug's presence and activity in the body. The study does not involve any changes to the therapeutic management of the patients. Throughout the study, patients will be monitored from the first day of venetoclax administration to the end of treatment, including up to 28 days at the conclusion of the first venetoclax cycle. Researchers will evaluate the best pharmacokinetic indicators of treatment response using both biological and clinical endpoints. The study involves minimal risks, primarily related to blood sample collection and clinical data gathering, ensuring close safety monitoring during the entire observation period.

Very little information is available about hypoparathyroidism, a condition that can lead to complications such as low calcium symptoms, calcifications in various tissues, kidney stones, and kidney problems. No specific data exists for France, so researchers are gathering detailed information about the condition, its treatments, and related complications in French patients. This research aims to better understand how hypoparathyroidism affects people in France over about two years. No treatments or interventions will be given as part of this study. Instead, the study will collect and analyze existing data on patients diagnosed with chronic hypoparathyroidism who live in France. This approach allows researchers to observe real-world experiences without changing patient care. Participants will provide information that helps assess the overall patterns, treatments, and complications related to hypoparathyroidism. This includes tracking how common the condition is and monitoring any complications during the study. The study will continue until its completion, which is expected to be around two years, focusing on gathering comprehensive epidemiological data.