Villeneuve Saint Georges

Researchers are studying the biological features of advanced ALK-rearranged non-small cell lung cancer (NSCLC) in patients treated with new generation tyrosine kinase inhibitors (TKIs) as their first therapy. This study is part of the national EXPLORE ALK cohort, a multi-center observational project in France, focusing on patients with this specific genetic alteration. The goal is to better understand the tumor biology and resistance mechanisms by analyzing samples from diagnosis through disease progression. The study collects tumor tissue samples at diagnosis and, when possible, at disease progression for RNA sequencing to identify ALK fusion partners, variants, and co-mutations. Blood samples are also taken at diagnosis, first tumor evaluation, and at progression to analyze circulating tumor DNA (ctDNA) using next-generation sequencing panels that detect mutations, fusions, and other genetic changes. These biological analyses are centralized at specialized centers such as the Léon Bérard Center and Rouen University Hospital. Patients are treated with approved ALK inhibitors like alectinib, brigatinib, lorlatinib, or entrectinib as part of their standard care. Participants will provide blood samples at multiple time points and, if possible, tumor biopsy samples for detailed genetic analysis. Researchers will monitor the progression-free survival from treatment start for up to 72 months. The study involves regular evaluations to assess tumor status and collect biological material to track genetic changes over time. Consent for sample collection and participation in the study is required, and patient data is managed within the national health system framework.

The study proposes to test an intervention consisting of dual long-acting HIV-specific broadly neutralizing antibodies (3BNC117-LS \& 10-1074-LS ) + ART, at primary HIV-1 infection, and to compare it to ART only regarding HIV-1 replication. The study aims to enrol 69 participants in French (Ile-de-France) clinical centres. Participants will have been diagnosed with primary HIV-1 infection, will start ART during early phase of Primary HIV infection, and will interrupt ART 52 weeks later. Study duration will vary by participant, depending on the time of ART interruption and the time to viral rebound.

Researchers are conducting the Dataids cohort, a long-term prospective study involving over 30,000 HIV-infected patients receiving care at more than 15 HIV centers across France. The study aims to monitor clinical practices, track changes in the course of HIV and related infections, and evaluate factors influencing the clinical, immunological, and virological progression of HIV. It also focuses on assessing antiretroviral therapy (ART) effectiveness and monitoring hepatitis C virus (HCV) treatment outcomes. Participants in the study include HIV-1 infected patients regardless of their CD4 cell count or ART status. Data collection occurs as part of routine outpatient clinic visits, with annual gathering of demographic, immunological, virological, serological, laboratory, therapeutic, and clinical information. The cohort has been ongoing since 2010, reflecting real-world clinical care and treatment patterns in France. Throughout the study, researchers track participants’ HIV plasma viral load to evaluate treatment success, specifically measuring the proportion of patients with viral loads below 50 copies/mL over an average of six months from enrollment. Data on co-infections such as hepatitis B and C, as well as syphilis, are also collected. This observational design allows ongoing surveillance of HIV infection trends and treatment effectiveness, supporting improved care quality for HIV patients in France.

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.

There is a wide variation in how rapid sequence induction is performed in operating rooms worldwide. This study aims to describe how French anesthesiologists prevent serious blood flow problems during rapid sequence anesthetic induction in adult patients. It focuses on the occurrence of major hemodynamic disorders, such as low or high blood pressure, sustained arrhythmias, or cardiac arrest within the first 10 minutes after anesthesia begins. Participants will undergo rapid sequence anesthetic induction, a process used to quickly induce general anesthesia for patients at high risk of lung fluid aspiration. The study will observe the clinical practices of pre-oxygenation, induction, and intubation, and check how well these practices follow the formal expert recommendations from 2017 and 2018. Data on the prevention of gastric fluid inhalation, equipment used, drugs administered, and clinical parameters will be collected during the induction process. Throughout the study, researchers will monitor neurological and cardio-respiratory signs and record any complications within the first 10 minutes after anesthesia induction. The main outcome measured is the occurrence of major hemodynamic disorders during this period. The study is observational and multicenter, involving adult patients undergoing rapid sequence induction in France.

The emergence of extended-spectrum beta-lactamase-producing Enterobacteriaceae (E-ESBL) is an important public health concern, especially in children with urinary tract infections (UTIs). These bacteria can lead to increased use of penem antibiotics, which may cause resistant strains. This study evaluates the effects of different antibiotic treatments on the presence of E-ESBL in the digestive tract of children aged 3 months to under 3 years who have febrile UTIs. The goal is to compare the impact of intravenous amikacin versus intravenous or intramuscular ceftriaxone or oral cefixime on the emergence of these bacteria in stools. Participants receive one of the antibiotic treatments as monotherapy: amikacin given intravenously, ceftriaxone administered either intravenously or intramuscularly, or cefixime taken orally. Before starting treatment, an anorectal swab is collected to check for E-ESBL bacteria, and a second swab is taken three to four days after beginning the antibiotic therapy to monitor any changes. During the study, children are monitored for the presence of E-ESBL in their stools on day 4 through these swabs. Parents provide consent and confirm their understanding of the study information. The study measures the bacterial carriage in the digestive tract after treatment and ensures safety by excluding children currently hospitalized or on multiple antibiotics. The participation duration aligns with the timing of these assessments.

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.