[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495547":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":156,"collaborators":159,"id":209,"slug":210,"hasResults":211,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":217,"sex":218,"minAge":219,"maxAge":220,"enrollmentInfo":221,"targetDuration":224,"studyType":225,"phases":10,"briefSummary":226,"conditions":227,"keywords":232,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},{"fullName":5,"class":6},"San Raffaele University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early onset colorectal cancer",null,"Patients with colorectal cancer diagnosed before the age of 50 years",[13],"Behavioral: Semi Quantitative Food Frequency Questionnaire (SQFFQ)",{"label":15,"type":10,"description":16,"interventionNames":17},"Control","Individuals meeting all the following:\n\n* aged \\\u003C50 years\n* no history of colorectal cancer\n* at least one negative screening test (at least a fecal occult blood test with high sensitivity)",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"BEHAVIORAL","Semi Quantitative Food Frequency Questionnaire (SQFFQ)","The SQFFQ quantifies the frequency of consumption of each food and drink and the following list of variables:\n\n* date of birth\n* sex\n* ethnicity\n* weight (kg)\n* height (m)\n* BMI (kg\u002Fm2) at the time of eoCRC diagnosis and at 18 years old\n* country where they live permanently\n* tobacco smoking at the time of eoCRC diagnosis and at 18 years old\n* sitting time\n* TV-viewing time\n* moderate-to-vigorous physical activity (MVPA)\n* waist circumference (cm)\n* home blood pressure levels (mmHg)\n* fasting blood glucose (mg\u002Fdl)\n* regular consumption of aspirin\u002FNSAID and years of consumptions\n* calcium and folate supplements and years of consumptions\n* oral contraceptive agents and years of consumptions\n* post-menopausal hormones and years of consumptions",[15,9],[25],{"name":26,"affiliation":27,"role":28},"Giulia Martina Cavestro, MD PhD","IRCCS San Raffaele Scientific Institute","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":33,"email":34},"CONTACT","0226435508","+39","cavestro.giuliamartina@hsr.it",[36,54,68,82,96,108,128,142],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Department of Medicine-Gastroenterology, Denver Veterans Affairs Medical Center, University of Colorado Hospital","RECRUITING","Denver","Colorado","80045","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-104.9847,39.73915,{"lat":48,"lon":47},[51],{"name":52,"role":31,"phone":10,"phoneExt":10,"email":53},"Swati Patel","Swati.Patel@cuanschutz.edu",{"facility":55,"status":38,"city":56,"state":57,"zip":58,"country":42,"countryCode":43,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine University of Chicago Medicine","Chicago","Illinois","60637",{"type":45,"coordinates":60},[61,62],-87.65005,41.85003,{"lat":62,"lon":61},[65],{"name":66,"role":31,"phone":10,"phoneExt":10,"email":67},"Sonia Kupfer","skupfer@medicine.bsd.uchicago.edu",{"facility":69,"status":38,"city":70,"state":10,"zip":10,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Department of Gastrointestinal Surgery, Helsinki University Hospital","Helsinki","Finland","FI",{"type":45,"coordinates":74},[75,76],24.93545,60.16952,{"lat":76,"lon":75},[79],{"name":80,"role":31,"phone":10,"phoneExt":10,"email":81},"Toni T Seppala","tseppala@me.com",{"facility":83,"status":38,"city":84,"state":10,"zip":10,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Department of General, Visceral and Transplant Surgery, Hospital of the University of Munich (LMU)","Munich","Germany","DE",{"type":45,"coordinates":88},[89,90],11.57549,48.13743,{"lat":90,"lon":89},[93],{"name":94,"role":31,"phone":10,"phoneExt":10,"email":95},"Florian Kuhn, MD","Florian.Kuehn@med.uni-muenchen.de",{"facility":97,"status":38,"city":98,"state":10,"zip":10,"country":85,"countryCode":86,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Gabriela Moslein","Wuppertal",{"type":45,"coordinates":100},[101,102],7.14816,51.25627,{"lat":102,"lon":101},[105],{"name":106,"role":31,"phone":10,"phoneExt":10,"email":107},"Gabriela Moslein, MD","gmoeslein@outlook.de",{"facility":109,"status":38,"city":110,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Prof Giulia Martina Cavestro, MD PhD","Milan","Lombardy","20132","Italy","IT",{"type":45,"coordinates":116},[117,118],9.18951,45.46427,{"lat":118,"lon":117},[121,123,126],{"name":122,"role":31,"phone":32,"phoneExt":33,"email":34},"Giulia Martina Cavestro, MD, PhD",{"name":124,"role":125,"phone":10,"phoneExt":10,"email":10},"Marta Puzzono, MD","SUB_INVESTIGATOR",{"name":127,"role":125,"phone":10,"phoneExt":10,"email":10},"Alessandro Mannucci, MD",{"facility":129,"status":38,"city":130,"state":10,"zip":10,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Division of Cancer Medicine, Oslo University Hospital (OUS), Institute for Cancer Genetics and Informatics Norwegian Radium Hospital","Oslo","Norway","NO",{"type":45,"coordinates":134},[135,136],10.74609,59.91273,{"lat":136,"lon":135},[139],{"name":140,"role":31,"phone":10,"phoneExt":10,"email":141},"Mev Dominguez Valentin","mev.dominguez.valentin@rr-research.no",{"facility":143,"status":38,"city":144,"state":10,"zip":10,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Department of Gastroenterology, Hospital Clínic de Barcelona, University of Barcelona","Barcelona","Spain","ES",{"type":45,"coordinates":148},[149,150],2.15899,41.38879,{"lat":150,"lon":149},[153],{"name":154,"role":31,"phone":10,"phoneExt":10,"email":155},"Francesc Balaguer Prunès","FPRUNES@clinic.cat",{"type":28,"investigatorFullName":157,"investigatorTitle":158,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Cavestro Giulia Martina MD PhD","Prof Cavestro Giulia Martina",[160,163,165,167,169,171,173,175,177,179,181,183,185,187,189,191,193,195,197,199,201,203,205,207],{"name":161,"class":162},"Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy","UNKNOWN",{"name":164,"class":162},"Ospedale Civile Guglielmo da Saliceto, Piacenza, Italy",{"name":166,"class":6},"Centro di Riferimento Oncologico - Aviano",{"name":168,"class":6},"Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari",{"name":170,"class":6},"University Hospital Padova",{"name":172,"class":6},"Azienda Ospedaliero-Universitaria Careggi",{"name":174,"class":162},"IRCCS Arcispedale S. Maria Nuova - Azienda Ospedaliera di Reggio Emilia, Reggio Emilia, Italy",{"name":176,"class":6},"Azienda Ospedaliera San Gerardo di Monza",{"name":178,"class":162},"Azienda ULSS5 Polesana, Rovigo, Italy",{"name":180,"class":162},"Istituto Tumori Regina Elena - IRCCS IFO, Roma, Italy",{"name":182,"class":162},"IRCCS De Bellis, Castellana Grotte, Italy",{"name":184,"class":162},"University Hospital HELIOS Klinikum Wuppertal, Center for Hereditary Tumors, University of Witten-Herdecke, Wuppertal, Germany",{"name":186,"class":6},"Ludwig-Maximilians - University of Munich",{"name":188,"class":6},"Hospital Clinic of Barcelona",{"name":190,"class":162},"Helsinki University Hospital, Helsinki, Finland",{"name":192,"class":162},"Oslo University Hospital (OUS), Institute for Cancer Genetics and Informatics Norwegian Radium Hospital, Oslo, Norway",{"name":194,"class":6},"University of Chicago",{"name":196,"class":162},"University of Colorado Hospital, CO, USA",{"name":198,"class":162},"University of Michigan Ann Arbor, Michigan, USA",{"name":200,"class":6},"Columbia University",{"name":202,"class":162},"The James Comprehensive Cancer Center, Columbus, OH, USA",{"name":204,"class":6},"Ohio State University",{"name":206,"class":6},"The Cleveland Clinic",{"name":208,"class":162},"Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Victoria, Australia","100495547","exogenous-and-endogenous-risk-factors-for-early-onset-colorectal-cancer-100495547",false,"NCT05732623","Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer","Diet obEsity sMoking Epigenetics geneTics biomaRkers Physical Activity: An International Multicenter Case-control Study on Endogenous and Exogenous Risk Factors in Early-onset Colorectal Cancer","DEMETRA","Inclusion Criteria:\n\n* All sexes eligible\n* (for Cases) eoCRC diagnosed between 18 and 49 years and confirmed by histology (biopsy or surgical specimen in case of surgery)\n* (for Controls) negative past and present history of cancer; negative fecal occult blood test (FOBT), or negative colonoscopy.\n\nExclusion Criteria:\n\n* CRC diagnosed at ≥ 50 years\n* Diseases that can modify the dietary regimen (celiac disease, diabetes)\n* Diseases that are known to predispose to eoCRC (personal past or recent history of inflammatory bowel disease, past history of pelvic irradiation)\n* Unable to give written consents and to fill in the electronic questionnaire",true,"ALL","18 Years","49 Years",{"count":222,"type":223},2300,"ESTIMATED","10 Years","OBSERVATIONAL","An increase in early-onset colorectal cancers (eoCRC), defined as a CRC before 50 years, is confirmed globally.\n\nCRC pathogenesis has been associated with several risk factors (family history, germline pathogenic variants, obesity, alcohol, physical activity, red meat, and a Western diet).\n\nDesign: an international, multicenter, retrospective case-control study of prospectively enrolled patients; low-risk intervention study as it will perform a fecal occult blood test Endpoint: predictive power of a semi-quantitative food frequency questionnaire (SQFFQ) developed for eoCRC.\n\nCases: Patients with a recent diagnosis of eoCRC (within 2 years from enrollment).\n\nControls: matched by age (matching range ± 5 years) and sex. Healthy volunteers will be mainly enrolled among workers within the participating hospital center. The enrolled healthy volunteers will perform a fecal occult blood test.\n\nVariables of interest: age, sex, ethnicity, BMI at the time of eoCRC diagnosis and at 18 years old, country, tobacco smoking at the time of eoCRC diagnosis and at 18 years old, sitting time, TV-viewing time, moderate-to-vigorous physical activity (MVPA), waist circumference (cm), home blood pressure levels (mmHg), fasting blood glucose (mg\u002Fdl), regular consumption of aspirin\u002FNSAID, calcium and folate supplements, oral contraceptive agents, post-menopausal hormones and years of consumptions, if the filled questionnaire reflects diet for the last 5-10 years before.\n\nCases only: date of eoCRC diagnosis, symptoms at diagnosis, eoCRC localization, eoCRC stage, histological diagnosis, type of surgery, and date (if performed), chemotherapy and radiotherapy (if performed), vital status and duration of follow-up, family history of CRC and other cancers (uterus, ovary, stomach, small intestine, urinary tract\u002Fbladder\u002Fkidney, bile ducts, brain, pancreas, skin tumors), type of germline pathogenetic variant (if performed).\n\nBefore the case-control study, three non-consecutive 24-hour Dietary Recalls (24hDRs) will validate the SQFFQ.\n\nThe SQFFQ will be administered to the validation study group during three non-consecutive calls, including one non-weekday (30-minute 24-h-recall computer-aided personal interview).\n\nPrimary Objective To measure the relative risk of specific dietary and lifestyle factors (smoking habit, alcohol intake, physical activity) for early-onset colorectal cancer in countries where eoCRC incidence is increasing versus stable\u002Fdecreasing",[228,229,230,231],"Colorectal Cancer","Early Onset Colorectal Cancer","Diet Habit","Risk Reduction",[233,234,235,236,237,238,239,240],"Early onset","Young onset","Young adult","Colon cancer","Rectal cancer","Cancer genetics","Cancer risk factors","Diet","2026-04-21",{"date":243,"type":244},"2026-04-24","ACTUAL",{"date":246,"type":244},"2022-12-05",{"date":248,"type":223},"2035-01",{"name":5,"class":6},8]