[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Firalis SA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":100},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100645158","alzevit-nationwide-digital-apoe-4-cohort-for-early-alzheimers-disease-prevention-and-trial-readiness-100645158",false,"NCT07679906","ALZEVIT: Nationwide Digital APOE ε4 Cohort for Early Alzheimer's Disease Prevention and Trial Readiness","ALZEVIT: A Nationwide Decentralized Digital Cohort for Population APOE Genotyping, Longitudinal Characterization of APOE ε4\u002Fε4 Trajectories, and Trial-readiness for Precision Prevention in Early Alzheimer's Disease","ALZEVIT","Inclusion Criteria:\n\n* Participants who sign the electronic Informed Consent form.\n* Adults aged over 45 years old (inclusive) at the time of consent.\n* Participants residing in France.\n* Participants able to read and understand the study information in French or with the help of a legal representative.\n* Participants are capable of electronically signing the consent form.\n* Participants affiliated with the French national health insurance system.\n* Participants with access to the internet and a valid email address.\n* Participants can self-collect and return a saliva sample using a provided kit (ORAcollect® Dx device).\n\nExclusion Criteria:\n\n* Participants who do not sign the Informed Consent form.\n* Participants who are unable to read or understand French.\n* Participants younger than 45 years at the time of consent.\n* Participants with known cognitive impairments, severe dementia, or psychiatric conditions that prevent informed consent.\n* Participants with a documented substance use disorder (alcohol or drug dependence) within the past 24 months.\n* Participants who cannot be reliably contacted by email or phone.\n* Participants previously enrolled in the ALZEVIT study or its pilot phase.\n* Participants who are legally protected adults or under guardianship, curatorship, or judicial\u002Fadministrative custody.\n* Participants whose physical condition does not allow them to perform the tasks required by the study.\n* Participants who, in the judgment of the Investigator, are unlikely to comply with study procedures.\n* Participants who are study staff (investigators, sub-investigators, coordinators, assistants) or their immediate family members.\n* Participants who are incarcerated or deprived of liberty by judicial or administrative decision.\n* Participants with any disease or condition that, in the opinion of the Investigator, would compromise participation or safety.",true,"ALL","45 Years",{"count":21,"type":22},50000,"ESTIMATED","OBSERVATIONAL","ALZEVIT is a nationwide, decentralized, digital-first cohort study in France designed to establish a large-scale Apolipoprotein E (APOE) genotyping registry and enable precision prevention strategies for Alzheimer's disease (AD). Sponsored by Firalis SA and conducted in collaboration with French memory centers, it addresses the need for early identification of individuals at high genetic risk, particularly APOE ε4 carriers and ε4\u002Fε4 homozygotes, in the context of emerging disease-modifying therapies most effective in preclinical or early disease stages.\n\nUsing an online recruitment platform, participants aged ≥45 years provide electronic informed consent and self-collected saliva samples via home collection kits for centralized APOE genotyping using the APO-Easy® assay, compliant with EU IVDR and US FDA requirements. Data are stored in a secure registry compliant with GDPR.\n\nPhase A (0-18 months) will enroll 50,000 participants to determine national APOE genotype distribution, identify high-risk individuals, and evaluate feasibility of large-scale digital genetic screening, with longitudinal online follow-up including cognitive and risk factor assessments.\n\nPhase B (12-24 months) includes detailed phenotyping of \\~2,350 selected participants across all APOE genotypes, including \\~750 ε4\u002Fε4 homozygotes. Participants undergo clinical evaluation, MRI, cognitive testing, and multi-omics biomarker profiling (genomics, proteomics, metabolomics, environmental exposure), conducted at memory centers or via telemedicine.\n\nThe study classifies participants along the cognitive continuum, including cognitively normal individuals, preclinical AD, mild cognitive impairment (MCI), and mild or moderate AD, to identify genotype-specific trajectories and modifiable risk and resilience factors. ALZEVIT aims to establish a scalable national infrastructure linking genetic stratification with longitudinal biomarker and clinical data to support prevention trials, improve understanding of APOE-related heterogeneity, and advance precision medicine for Alzheimer's disease.",[26],"Alzheimer",[28,29,30],"APOE ε4\u002Fε4","Genetic Risk Profiling","Alzheimer's Disease","RECRUITING","2026-06-25",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":22},"2026-07",{"date":39,"type":22},"2028-05-01",{"name":41,"class":42},"Firalis SA","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":17,"sex":18,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":43},"100451579","validation-of-the-stability-of-diagnostic-biomarkers-on-healthy-volunteers-100451579","NCT05160337","Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers","Clinical Study on Healthy Volunteers for Validating the Stability of Different Diagnostic Biomarkers Studied at Firalis","Inclusion Criteria:\n\n* Participants who sign the informed consent forms for sample collection and data collection both anonymized and reported in CRF.\n* Able to comply with all study procedures.\n* Healthy Volunteers having no apparent disease.\n* Adults, both genders, aged 18-85 years.\n* Participants with no apparent motor or mental health abnormality.\n* Participants having no major disabling mental or physical disability that would require hospitalization.\n* Body weight above 50 kg if male, above 40 kg if female.\n\nExclusion Criteria:\n\n* Any subject who did not sign the Informed Consent form.\n* Any subject who, in the judgment of the Investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development.\n* Any subject in the exclusion period of a previous study according to applicable regulations.\n* Any subject who cannot be contacted in case of emergency.\n* Any subject who is the Investigator or any sub-investigator, research assistant, study coordinator, or other staff thereof, directly involved in the conduct of the protocol.\n* Any subject with a disease that, in the judgement of the investigator, would interfere with the conduct of study or harm the safety of volunteer.\n* Subjects with disabling disease or abnormal health status are excluded.\n* Subjects aged below 18 years and older than 85 years are excluded.\n* Pregnant, parturient and nursing women are excluded.\n* Subjects deprived of their liberty by a judicial or administrative decision, protected adults and vulnerable persons are excluded.\n* Subjects who are under legal protection or who are unable to express their consent are not included.\n* Any subject who reports in the questionnaire of the screening period having one of the following diseases is excluded:\n\n  * Any psychiatric or neurodegenerative disease or neurologic disorder.\n  * Hypertension.\n  * Any cardiovascular disease.\n  * Any chronic inflammatory disease such as rheumatoid arthritis.\n  * Any cancer.\n  * Frequent headaches and\u002For migraine, recurrent nausea and\u002For vomiting.\n* Any subject who did a blood donation, any volume, within 2 months before inclusion.\n* Any subject who reports in the questionnaire of the screening period having medication(s) for one or more of the above diseases is excluded.\n* Drug or alcohol abuse or smoking more than 10 cigarettes or equivalent.\n* Subjects with no apparent disease and symptoms, but with unknown Covid-19 positivity are not excluded.","18 Years","85 Years",{"count":54,"type":22},60,"INTERVENTIONAL",[57],"NA","Stability studies on the peripheral biomarkers (lncRNAs, sncRNAs, mRNAs, proteins, lipids\u002Fmetabolites) measured by Firalis IVD test candidates and effect of gender, age, nutrition on their expression level",[60],"Healthy",[62,63,64,65],"biomarkers","chronobiology","healthy volounteers","diagnostic biomarkers","2026-06-22",{"date":68,"type":35},"2026-06-24",{"date":70,"type":35},"2025-06-18",{"date":72,"type":22},"2027-04",{"name":41,"class":42},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100555725","multicentre-study-for-data-collection-development-and-evaluation-of-novel-crc-screening-and-diagnostic-methods-100555725","NCT06515821","Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods","Multicentre Observational Study for the Data Collection, Development and Evaluation of the Performance of Novel CRC Screening and Diagnostic Methods ONCOSCREEN-CS","Inclusion Criteria:\n\n* CRC Group\n\n  1. Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study.\n  2. Subjects aged ≥18 years\n  3. Subject is willing to undergo FOBT test, colonoscopy, and tissue biopsy\n  4. Subject for whom the decision to perform a colonoscopy has been made by the treating physician\n  5. Subject has positive CRC diagnosis according to colonoscopy result\n  6. Covered by a Health Insurance System\n  7. Subject is able to comply with all study procedures\n* Control Group with risks and presence of polyps\n\n  1. Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study.\n  2. Subjects aged ≥18 years\n  3. Otherwise healthy individuals with recognized risk factors for CRC development defined by either heredity and\u002For obesity and\u002For smoking and\u002For excess alcohol consumption and\u002For hyperlipidaemia.\n  4. Subject be willing to undergo FOBT test, colonoscopy, and tissue biopsy\n  5. Subject has negative CRC diagnosis according to colonoscopy result\n  6. Covered by a Health Insurance System, which will cover colonoscopy as screening in patients with risk factors and alarm symptoms such as abdominal pain, change in stool texture, change in stool frequency, blood in stool\u002Frectal bleeding, diarrhea, constipation, abdominal bloating, weight loss, tiredness.\n* Control Group with risks and absence of polyps\n\n  1. Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study.\n  2. Subjects aged ≥18 years\n  3. Otherwise healthy individuals with recognized risk factors for CRC development defined by either heredity and\u002For obesity and\u002For smoking and\u002For excess alcohol consumption and\u002For hyperlipidaemia.\n  4. Subject be willing to undergo FOBT test, colonoscopy, and tissue biopsy\n  5. Subject has negative CRC diagnosis according to colonoscopy result\n  6. Covered by a Health Insurance System, which will cover colonoscopy as screening in patients with risk factors and alarm symptoms such as abdominal pain, change in stool texture, change in stool frequency, blood in stool\u002Frectal bleeding, diarrhea, constipation, abdominal bloating, weight loss, tiredness.\n* Control Group with no risks\n\n  1. Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study.\n  2. Subjects aged ≥40 years\n  3. Otherwise healthy individuals without any recognized risk factors for CRC development defined by either heredity and\u002For obesity and\u002For smoking and\u002For excess alcohol consumption and\u002For hyperlipidemia.\n  4. Subject be willing to undergo FOBT test\n  5. Subject has negative FOBT result\n\nExclusion Criteria:\n\n* For the CRC Group\n\n  1. Legal incapacity or limited legal capacity\n  2. Subject did not sign the Informed Consent form\n  3. Subject who, according to the investigator's assessment, presents with an unstable medical condition contraindicating the performance of the planned blood test, stool test or breath test\n  4. Subject has had surgery in the previous 6-8 weeks or is under medication for CRC treatment.\n* For the control groups\n\n  1. Legal incapacity or limited legal capacity\n  2. Subject did not sign the Informed Consent form\n  3. Previous history of any type of cancer\n  4. Gastrointestinal disorders or other serious acute or chronic diseases",{"count":82,"type":22},4100,"The primary goal is to develop easy accessible diagnostic tools for high risk subjects for colon cancer in different European populations to improve early CRC detection. These CRC screening technologies would be low cost, breakthrough and of high sensitivity and specificity.",[85],"Colorectal Cancer",[87,62,88,89,90],"early CRC detection","diagnostic tool","high risk subject","colorectal cancer","2025-09-09",{"date":93,"type":35},"2025-09-10",{"date":95,"type":35},"2024-08-01",{"date":97,"type":22},"2026-12-31",{"name":41,"class":42},8,""]