protocolSection identificationModule nctId: NCT06342401, orgStudyIdInfo id: 23228/ENCODE, briefTitle: Early Onset Colorectal Cancer Detection, acronym: ENCODE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-15, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2025-10-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, descriptionModule briefSummary: Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men and the second for young women.This study aims to detect EOCRC with a non-invasive test, using a blood-based molecular assay based on microRNA (ribonucleic acid), conditionsModule conditions: Colorectal Cancer, conditions: Colorectal Neoplasms, conditions: Colorectal Adenocarcinoma, conditions: Colorectal Cancer Stage I, conditions: Colorectal Cancer Stage IV, conditions: Colorectal Cancer Stage II, conditions: Colorectal Cancer Stage III, conditions: Colorectal Neoplasms Malignant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: ENCODE, outcomesModule primaryOutcomes measure: Sensitivity, secondaryOutcomes measure: Specificity, secondaryOutcomes measure: Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: City of Hope Medical Center, status: RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, contacts name: Ajay Goel, PhD, role: CONTACT, phone: 626-218-3452, email: AJGOEL@COH.ORG, contacts name: Alessandro Mannucci, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.13945, lon: -117.97729, locations facility: IRCCS San Raffaele, status: RECRUITING, city: Milan, country: Italy, contacts name: Giulia Martina Cavestro, MD, PhD, role: CONTACT, email: cavestro.giuliamartina@hsr.it, contacts name: Alessandro Mannucci, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Giulia Martina Cavestro, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Kawasaki University, status: RECRUITING, city: Kawasaki, country: Japan, geoPoint lat: 35.52056, lon: 139.71722, locations facility: Mie University, status: RECRUITING, city: Mie, country: Japan, locations facility: National Cancer Center Hospital, status: RECRUITING, city: Tokyo, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Tokyo Medical and Dental University, status: RECRUITING, city: Tokyo, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Yamagata University, status: RECRUITING, city: Yamagata, country: Japan, geoPoint lat: 38.23333, lon: 140.36667, locations facility: Barcelona University, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Francesc Balaguer, MD, PhD, role: CONTACT, email: fprunes@clinic.cat, geoPoint lat: 41.38879, lon: 2.15899, locations facility: University of La Laguna, status: RECRUITING, city: La Laguna, country: Spain, geoPoint lat: 28.4853, lon: -16.32014, locations facility: Salamanca Biomedical Research Institute, status: RECRUITING, city: Madrid, country: Spain, contacts name: Jose Perea, MD, role: CONTACT, email: josepereag@hotmail.com, contacts name: Jose Perea, MD, role: SUB_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False