[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555725":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":170,"collaborators":172,"id":175,"slug":176,"hasResults":177,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":10,"eligibilityCriteria":181,"healthyVolunteers":177,"sex":182,"minAge":183,"maxAge":10,"enrollmentInfo":184,"targetDuration":10,"studyType":187,"phases":10,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"Firalis SA","INDUSTRY",[8,14,18,21],{"label":9,"type":10,"description":11,"interventionNames":12},"CRC Group",null,"Subject has positive CRC diagnosis according to colonoscopy result",[13],"Diagnostic Test: ONCOSCREEN",{"label":15,"type":10,"description":16,"interventionNames":17},"Control Group with risks and presence of polyps","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.",[13],{"label":19,"type":10,"description":16,"interventionNames":20},"Control Group with risks and absence of polyps",[13],{"label":22,"type":10,"description":23,"interventionNames":24},"Control Group with no risks","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.",[13],[26],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"DIAGNOSTIC_TEST","ONCOSCREEN","Subjects samples will be tested with diagnostic tests.",[9,22,19,15],[32],{"name":33,"affiliation":34,"role":35},"Markus MOELHER, MD, PhD","University Medical Center Mainz","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Federica ZILLI, PhD","CONTACT","+33 (0) 389911320","federica.zilli@firalis.com",{"name":43,"role":39,"phone":10,"phoneExt":10,"email":44},"Céline Meyer","celine.meyer@firalis.com",[46,62,73,89,107,121,138,156],{"facility":47,"status":48,"city":49,"state":10,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Military Medical Academy Sofia, Gastroenterology Clinic, 3 Sveti Georgi Sofiiski str., Sofia 1606, Bulgaria","RECRUITING","Sofia","1606","Bulgaria","BG",{"type":54,"coordinates":55},"Point",[56,57],23.32415,42.69751,{"lat":57,"lon":56},[60],{"name":61,"role":39,"phone":10,"phoneExt":10,"email":10},"Daniela Stoyanova, Prof. Dr.",{"facility":63,"status":64,"city":49,"state":10,"zip":65,"country":51,"countryCode":52,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"University Specialised Hospital for Active Treatment of Oncology Departement of Gastroenterology.","NOT_YET_RECRUITING","1797",{"type":54,"coordinates":67},[56,57],{"lat":57,"lon":56},[70],{"name":71,"role":39,"phone":10,"phoneExt":10,"email":72},"Bozhidar TOMOV, MD","btomov@sbaloncology.bg",{"facility":74,"status":64,"city":75,"state":10,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"UFC: Université de Franche-Comté Oncology department CHU Besançon","Besançon","25030","France","FR",{"type":54,"coordinates":80},[81,82],6.01815,47.24878,{"lat":82,"lon":81},[85],{"name":86,"role":39,"phone":87,"phoneExt":10,"email":88},"Christophe BORG, MD","+(33) 0 6 13 88 01 61","xtoph.borg@gmail.com",{"facility":90,"status":48,"city":91,"state":10,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"MKI UKSH Lübeck","Lübeck","23538","Germany","DE",{"type":54,"coordinates":96},[97,98],10.68729,53.86893,{"lat":98,"lon":97},[101,104],{"name":102,"role":39,"phone":10,"phoneExt":10,"email":103},"Jens MARQUARDT, MD","jens.marquardt@uksh.de",{"name":105,"role":39,"phone":10,"phoneExt":10,"email":106},"Annette Benderschiffer","annette.benderschiffer@uni-luebeck.de",{"facility":108,"status":48,"city":109,"state":10,"zip":110,"country":93,"countryCode":94,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"UMC Mainz: University Medical Center Mainz","Mainz-GE","55131",{"type":54,"coordinates":112},[113,114],8.25142,49.9903,{"lat":114,"lon":113},[117,120],{"name":118,"role":39,"phone":10,"phoneExt":10,"email":119},"Markus MOEHLER, Prof. Dr.","markus.moehler@unimedizin-mainz.de",{"name":118,"role":35,"phone":10,"phoneExt":10,"email":10},{"facility":122,"status":48,"city":123,"state":10,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"LSMU: Lithuanian University of Health Sciences Gastroenterology Department,","Kaunas","50161","Lithuania","LT",{"type":54,"coordinates":128},[129,130],23.90909,54.90156,{"lat":130,"lon":129},[133,136],{"name":134,"role":39,"phone":10,"phoneExt":10,"email":135},"Juozas KUPCINSKAS, MD","juozas.kupcinskas@lsmuni.lt",{"name":137,"role":39,"phone":10,"phoneExt":10,"email":10},"Laurynas Jarukas",{"facility":139,"status":48,"city":140,"state":10,"zip":141,"country":142,"countryCode":143,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"IPO: Instituto Português de Oncologia","Porto","4200-072","Portugal","PT",{"type":54,"coordinates":145},[146,147],-8.61097,41.1485,{"lat":147,"lon":146},[150,153],{"name":151,"role":39,"phone":10,"phoneExt":10,"email":152},"Mário DINIS RIBEIRO, MD","mario.ribeiro@ipoporto.min-saude.pt",{"name":154,"role":39,"phone":10,"phoneExt":10,"email":155},"Alda SILVA","gabinetedeprojetos@ipoporto.min-saude.pt",{"facility":157,"status":64,"city":158,"state":10,"zip":10,"country":159,"countryCode":160,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"IBO: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu București","Bucharest","Romania","RO",{"type":54,"coordinates":162},[163,164],26.10626,44.43225,{"lat":164,"lon":163},[167],{"name":168,"role":39,"phone":10,"phoneExt":10,"email":169},"Geanina Papuc, MD","papucgeanina@iob.ro",{"type":171,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[173],{"name":34,"class":174},"OTHER","100555725","multicentre-study-for-data-collection-development-and-evaluation-of-novel-crc-screening-and-diagnostic-methods-100555725",false,"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","ALL","18 Years",{"count":185,"type":186},4100,"ESTIMATED","OBSERVATIONAL","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.",[190],"Colorectal Cancer",[192,193,194,195,196],"early CRC detection","biomarkers","diagnostic tool","high risk subject","colorectal cancer","2025-09-09",{"date":199,"type":200},"2025-09-10","ACTUAL",{"date":202,"type":200},"2024-08-01",{"date":204,"type":186},"2026-12-31",{"name":5,"class":6},8]