Saint Denis

Malignant hypertension is a very severe type of high blood pressure that can be fatal if not treated. It mainly affects younger adults aged 35 to 55 and carries a high risk of serious heart and kidney problems. Despite its severity and increasing cases, research on malignant hypertension is limited, with diagnostic criteria and treatment guidelines that have not changed since 1929. This study aims to create the first prospective, multicenter registry to better understand the disease's epidemiology, care practices, and biological aspects, and to modernize its definition and diagnosis. The study plans to enroll 500 patients diagnosed with malignant hypertension based on classic criteria, including severe high blood pressure above 180/110 mmHg and evidence of organ damage. It will collect detailed data on patient characteristics, affected organs, and treatment approaches used in various centers. This registry will help develop new diagnostic and treatment recommendations based on solid scientific evidence and may lead to future therapeutic trials. Participants will be followed to evaluate their health outcomes over five years, focusing on their cardiovascular and renal prognosis. Researchers will analyze how patient profiles and the number and type of organ damage affect their long-term outlook. The study will document epidemiology, care pathways, organ involvement, and management strategies in detail to improve understanding and care of malignant hypertension.

Researchers are conducting a global study to understand the impact of moderate to severe alopecia areata (AA), non-segmental vitiligo (NSV), and hidradenitis suppurativa (HS) on adolescents and adults. This study aims to assess the burden these conditions place on patients' quality of life and daily functioning in a large real-world population. The study involves participants diagnosed by a physician with one of the three conditions: AA, NSV, or HS. There are no interventional treatments or medications being tested in this study, as it is observational in nature. Data collection focuses on patient-reported outcomes and measures that evaluate disease severity and its effects. Participants will complete various questionnaires and assessments related to their condition, such as the Alopecia Areata Symptom Impact Scale (AASIS) for AA, the Severity of Alopecia Tool (SALT) for scalp hair loss in AA, the Facial Vitiligo Area Scoring Index (F-VASI) and Vitiligo Quality of Life Score (VitiQoL) for vitiligo, and the Dermatology Life Quality Index (DLQI) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) for HS. These tools help researchers understand how symptoms affect quality of life and disease severity. The study collects information up to the day of the study visit.

This research evaluates treatments for acute lymphoblastic leukemia (ALL) in infants, children, and young adults up to 45 years old. It combines successful approaches from multiple European study groups into a master protocol with several randomized and interventional sub-studies. The goal is to improve survival rates while reducing treatment toxicity and relapse, especially focusing on better risk stratification and targeted therapies for different patient groups, including those with genetic differences and high relapse risk. The study uses a master protocol considered as standard care, with additional randomized interventions testing if treatment can be safely reduced in some risk groups or improved with new therapies in higher risk groups. Randomizations include testing omission of drugs like Doxorubicin or Vincristine+Dexamethasone pulses, adding Inotuzumab ozogamicin or 6-tioguanine to maintenance therapy, and treating certain patients with tyrosine-kinase inhibitors or Blinatumomab. The design allows flexible addition or stopping of sub-studies, and some interventions target specific patient subgroups such as those with ABL-class fusions or Down syndrome. Participants will undergo diagnosis confirmation and follow-up at participating centers and receive assigned treatments based on risk and randomization. Researchers monitor event-free survival, disease-free survival, and minimal residual disease response up to 5 to 8 years. Additional assessments include neurocognitive testing, pharmacokinetics of drugs like Imatinib and Asparaginase, cerebrospinal fluid analysis, and quality of life evaluations. Safety and long-term outcomes are closely tracked, with at least 5 years of follow-up for most measures.

The trial focuses on children, adolescents, and young adults under 22 years with newly diagnosed intracranial ependymoma, a type of brain tumor. It aims to improve patient outcomes by standardizing diagnosis and treatment, and by enhancing understanding of the disease's biology to guide future therapies. Patients are classified into three groups based on age, tumor location, and surgery results to test different treatment methods. Treatment varies by group. Patients aged over 12 months and under 22 years with complete tumor removal receive conformal radiotherapy followed by either 16 weeks of chemotherapy with VEC-CDDP or observation. Those with remaining disease receive chemotherapy with VEC or VEC plus high-dose methotrexate, conformal radiotherapy, and possibly an extra radiation boost if the tumor persists. Children younger than 12 months or those who cannot have radiotherapy receive intense chemotherapy with or without valproate. Patients not meeting these criteria join a registry for observation. Participants undergo central reviews of imaging and pathology to confirm diagnosis and tumor status. Assessments include MRI scans and biological marker evaluation. Treatment response, disease progression, and survival are tracked up to 4.5 years, with key outcomes including tumor removal success, progression-free survival, and number of responders at 15 months. Safety and adherence are monitored throughout treatment and follow-up.

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.

Researchers are evaluating antibiotic treatments for patients in intensive care with pneumonia caused by the bacteria Stenotrophomonas maltophilia. The study compares the effects of using either one antibiotic or a combination of two antibiotics, as well as treatment durations of 7 days versus 14 days, to determine which method helps patients survive better. It also studies how resistant the bacteria are to antibiotics and how often pneumonia recurs. The study involves patients who are intubated and mechanically ventilated in a medical intensive care unit. Participants receive either monotherapy or combination antibiotic therapy, with treatment lengths set at either 7 or 14 days. The approach aims to understand the best antibiotic strategy to improve survival outcomes in this critical setting. During the 28-day study period, researchers monitor patient survival as the primary outcome, tracking how different treatment strategies impact recovery. They assess bacterial resistance and pneumonia recurrence rates. The study includes hospitalized adults aged 18 years or older who meet the pneumonia diagnosis criteria, ensuring close follow-up and data collection to evaluate treatment effectiveness and safety.

Researchers are studying Philadelphia-negative myeloproliferative neoplasms (MPN), which include Polycythemia Vera (PV), essential thrombocythemia (ET), and prefibrotic myelofibrosis (PreMF). These chronic blood cancers involve specific mutations like JAK2V617F and carry a high risk of blood clots that can cause serious health problems. Current treatments include low-dose aspirin to reduce arterial clots, but patients still face risks of thrombosis and bleeding. This trial explores whether direct oral anticoagulants (DOACs), such as Apixaban or Rivaroxaban, might better prevent these clotting events in patients with the JAK2V617F mutation. Participants will be randomly assigned to receive either a DOAC (Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once daily) or low-dose aspirin (100 mg once daily). The study focuses on high-risk MPN patients with JAK2V617F mutation and will compare the effectiveness and safety of DOACs versus aspirin for preventing blood clots. Treatment will continue with close monitoring throughout the study. During the study, researchers will track the time until any arterial or venous blood clots occur over a 24-month follow-up period. Participants will undergo regular assessments to monitor clotting events, bleeding risks, and overall health. The trial aims to gather detailed information on how well these treatments prevent thrombosis and their safety profiles, helping to guide future care for patients with these blood disorders.

Researchers are evaluating the effects of different antibiotic infusion strategies in patients hospitalized in intensive care units with hospital-acquired sepsis caused by multidrug-resistant Gram-negative bacteria. This Phase 4 trial uses a 2x2 factorial design to compare continuous versus intermittent infusion of pivotal beta-lactam antibiotics and combination therapy with aminoglycosides versus monotherapy. The main goal is to assess 30-day mortality and major adverse kidney events in these patients. Participants are randomly assigned to one of four treatment groups: continuous infusion of beta-lactam antibiotics combined with a 5-day aminoglycoside infusion, intermittent infusion of beta-lactam antibiotics with a 5-day aminoglycoside infusion, continuous infusion of beta-lactam antibiotics with at most one dose of aminoglycoside, or intermittent infusion of beta-lactam antibiotics with at most one dose of aminoglycoside. Randomization also accounts for the type of beta-lactam administered. Treatments are delivered according to these infusion schedules during the ICU stay. During the study, patients will be monitored for vital outcomes including survival at 30 days after sepsis diagnosis and kidney function events such as the need for renal replacement therapy or persistent kidney dysfunction. Researchers will collect relevant clinical data and bacteriological samples before starting treatment. The study focuses on patients expected to stay in the ICU for more than three days and will observe their progress closely during the 30-day period following sepsis onset.

The BIOMEDE 2.0 study is a multicenter, randomized, open-label, controlled phase-3 trial that evaluates the efficacy of ONC201 compared to everolimus in patients with Diffuse Intrinsic Pontine Glioma (DIPG) and other related diffuse midline gliomas. The study aims to determine whether ONC201 is superior to everolimus in terms of progression-free survival (PFS) from randomization, either overall or in specific patient subgroups. This adaptive platform protocol allows treatment switching upon disease progression confirmed by a central review. Participants receive either everolimus tablets at a dose of 5 mg/m² once daily (capped at 10 mg) or ONC201 capsules at 375 mg/m² orally on Day 1 and Day 2 each week (capped at 625 mg per dose). All patients undergo radiotherapy with 30 daily fractions of 1.8 Gy totaling 54 Gy over 6 weeks, with possible dose increases for adults with certain tumor types. Radiotherapy starts within 4 to 6 weeks after biopsy or surgery, depending on the tumor type. In cases of metastatic or spinal tumors, radiotherapy timing and targeted treatment initiation are adjusted accordingly. During the study, participants are closely monitored through central reviews of disease progression based on radiological or histological evidence. The primary outcome is progression-free survival up to 2 years after the last patient is included. Safety and treatment tolerability are also assessed, along with biomarker evaluations obtained via biopsy or molecular analyses. The study continues treatment until confirmed progression, unacceptable toxicity, or withdrawal of consent.

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.