Reims

Researchers are evaluating new treatment options for adults with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This study compares the safety and effectiveness of adding calderasib and cetuximab, both targeted therapies, to a standard chemotherapy regimen called mFOLFOX6. The goal is to see if this combination can help patients live longer without their cancer growing or spreading compared to current treatments that may include mFOLFOX6 with or without bevacizumab. The study has two parts. It involves treatment with calderasib taken as an oral tablet, cetuximab given according to standard procedures, and mFOLFOX6 chemotherapy combining oxaliplatin, leucovorin/levofolinate calcium, and 5-fluorouracil. Some participants may receive bevacizumab or a bevacizumab biosimilar as part of the comparison. The treatments are given following approved dosing schedules. This design allows researchers to assess the safety and tolerability of these drug combinations in treating this type of colorectal cancer with the KRAS G12C mutation. Participants will be monitored for side effects, treatment tolerability, and cancer progression over a period that may last up to about 44 months. Researchers will track outcomes such as how many participants experience dose-limiting toxicities or adverse events, how many stop treatment due to side effects, and progression-free survival time. Assessments include health evaluations, laboratory tests, and imaging to observe cancer status. This long-term follow-up aims to understand both safety and effectiveness of the treatment combinations.

Researchers are studying patients with metastatic colorectal cancer (mCRC) who have a specific BRAFV600E mutation. This rare subtype of mCRC has poor prognosis and resistance to current treatments, especially in tumors with microsatellite stability or proficient mismatch repair. The study aims to collect detailed clinical data and biological samples to better understand treatment outcomes, resistance, and survival in real-world settings. Participants will provide blood samples and tumor tissue samples to support various research goals. The study will evaluate circulating tumor DNA during different lines of metastatic treatment to predict treatment response and resistance. It will also analyze the immune environment of BRAFV600E mCRC tumors and study specific subgroups with mismatch repair deficiencies. Clinical management data will be collected to inform future therapeutic approaches. During the study, patients will be monitored regularly with blood sample collections of 30 mL at each time point. Researchers will gather information about treatments, survival, and biological markers over time. The main outcome measured is overall survival from diagnosis up to five years. Patients must be able to comply with study procedures and provide informed consent. The study aims to improve knowledge of this aggressive cancer subtype and support development of new treatments.

Chronic inflammatory lung diseases such as asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, cystic fibrosis (CF), primary ciliary dyskinesia (PCD), and interstitial lung diseases (ILD) involve inflammation and changes in lung structure. These diseases show a wide range of clinical, functional, biological, and microbiological features, often overlapping between different conditions. Researchers are studying these shared and unique characteristics to better understand underlying disease mechanisms and identify new treatment targets beyond traditional diagnoses. This monocentric study at the University Hospital of Reims, France, will include adult patients diagnosed with asthma, COPD, bronchiectasis, CF, PCD, and idiopathic pulmonary fibrosis (IPF), along with healthy control volunteers. The study plans to enroll 470 participants over five years, from July 2025 to July 2030. Data will be collected at inclusion and during follow-up visits over ten years for patients, while controls will provide data only at inclusion. No specific treatments will be given as part of the study. Participants will provide information on demographics, respiratory disease history, symptoms, lung function tests, CT scans, and microbiological and pathological analyses when available. The study will analyze these data using statistical and machine learning methods to identify patient groups with shared disease traits and to develop predictive models for disease progression and treatment response. The goal is to improve understanding of the diversity and causes of chronic respiratory diseases to support personalized medicine approaches.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

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.

Researchers are creating a national, prospective cohort to study children with idiopathic nephrotic syndrome (INS), a rare kidney disease. The goal is to collect detailed data on patients treated in pediatric nephrology centers across France, Reunion Island, Mayotte, and eventually other French overseas territories. This structured follow-up aims to better understand the disease's characteristics and provide a foundation for future clinical trials. The study involves enrolling pediatric patients diagnosed with INS and systematically collecting clinical, biological, psychological, and social data. Biological samples such as blood, urine, hair, and nails will be gathered at disease onset before immunosuppressive treatment begins. Data will be recorded through medical records from hospital visits and consultations, supplemented by annual telephone interviews for patients without active disease. Quality of life, treatment adherence, and aesthetic impact questionnaires will also be collected and integrated into a secure database. Participants will be followed over at least two years, with data collected regularly by clinical research staff. This includes medical validation of clinical information, annual telephone follow-ups, and questionnaire assessments. The study's primary outcome is the number and characteristics of included cases over two years. This ongoing monitoring will support future nested studies and improve understanding of pediatric INS outcomes and management.

Researchers are studying children aged 8 to 18 years old undergoing multi-brackets orthodontic treatment to see if regular oral prevention and improved communication between dentists and orthodontists can reduce their risk of dental caries. The study compares two groups: a control group who completed treatment by 2024 without regular preventive follow-up, and a study group starting treatment in 2024 who receive semi-annual preventive consultations and use a digital communication tool to facilitate care coordination. The goal is to see if these measures decrease indicators of dental decay and plaque. Participants in the study group have oral prevention consultations every six months for up to four years. Dentists and orthodontists involved can use a new digital tool to share information and coordinate care. Data collected include caries indexes, ICDAS scores, plaque indexes, oral hygiene habits, and socio-professional categories. The control group data are collected at treatment completion and include similar dental health and risk measures. Throughout the study, participants undergo regular dental assessments every six months, including measuring DMFT index, plaque indexes, and caries scores. Researchers also collect information on brushing habits, diet, and oral health risks. Safety and oral health are monitored to evaluate the impact of the preventive program and digital communication tool over the average four-year treatment period.

Researchers are evaluating the effectiveness, safety, and tolerability of two different doses of remibrutinib compared to a placebo in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). This phase 3 study aims to determine how well remibrutinib works in treating this chronic skin condition characterized by painful abscesses and inflammatory nodules. The study lasts a total of 76 weeks and includes several phases: up to 4 weeks for screening, followed by a 16-week double-blind treatment period where participants receive either remibrutinib Dose A, Dose B, or a matching placebo. After this, there is a 52-week treatment period where all participants receive remibrutinib (Dose A or Dose B). Finally, a 4-week safety follow-up period occurs without treatment. Participants who stop treatment early are encouraged to stay in the study and complete the safety follow-up. During the study, participants will be regularly assessed for clinical response to treatment, focusing on the proportion achieving a 50% improvement in HS symptoms by week 16. Researchers will monitor safety and tolerability throughout the study, including during the follow-up period. Various evaluations such as physical exams and clinical assessments will be conducted to measure treatment effects and ensure participant safety over the entire 76-week duration.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating the effectiveness of combining imatinib with atezolizumab compared to imatinib alone in patients with unresectable advanced gastrointestinal stromal tumors (GIST) who have not responded to standard treatments including imatinib, sunitinib, and regorafenib. This phase II, prospective, randomized, multicenter study aims to assess disease control by measuring progression-free survival (PFS). Participants will be randomly assigned in a 1:1 ratio to one of two treatment groups: the experimental arm receiving oral imatinib 400 mg daily plus intravenous atezolizumab 1200 mg every three weeks, or the control arm receiving oral imatinib 400 mg daily alone. Treatment will continue for up to 12 months. The study also includes safety monitoring with an interim analysis planned after 6 months of follow-up for the first 12 patients. During the study, patients will have their disease progression monitored over 48 months using imaging and clinical assessments according to RECIST v1.1 criteria. Laboratory tests will evaluate organ function and safety, while data on adverse events will be collected systematically. Progression-free survival will be the primary outcome, analyzed with statistical methods considering tumor mutational status. All patient data will be recorded in electronic case report forms and monitored for compliance with the study protocol and regulations.