protocolSection identificationModule nctId: NCT06342440, orgStudyIdInfo id: 23228/AACRC, briefTitle: Early Detection of Advanced Adenomas and Colorectal Cancer, acronym: AACRC, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-03-15, primaryCompletionDateStruct date: 2025-12-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, descriptionModule briefSummary: This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses., conditionsModule conditions: Colorectal Cancer, conditions: Colorectal Neoplasms, conditions: Colorectal Polyp, conditions: Colorectal Adenocarcinoma, conditions: Colorectal Disorders, conditions: Colorectal Dysplasia, conditions: Colorectal Cancer Stage I, conditions: Colorectal Cancer Stage II, conditions: Colorectal Cancer Stage III, conditions: Colorectal Cancer Stage IV, conditions: Colorectal Neoplasms Malignant, conditions: Colorectal Serrated Adenocarcinoma, conditions: Colorectal Adenoma With Severe Dysplasia, conditions: Colorectal Adenoma With Mild Dysplasia, conditions: Colorectal Adenoma With Moderate Dysplasia, conditions: Colorectal Adenoma and Carcinoma 1, conditions: Colorectal Adenomatous Polyp, conditions: Colorectal Adenocarcinoma Metastatic in the Liver, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: DENEB, outcomesModule primaryOutcomes measure: Sensitivity, secondaryOutcomes measure: Specificity, secondaryOutcomes measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope Medical Center, status: RECRUITING, city: Monrovia, state: California, zip: 91016, country: United States, contacts name: Ajay Goel, PhD, role: CONTACT, phone: 626-218-3452, email: AJGOEL@COH.ORG, contacts name: Ajay Goel, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Caiming Xu, role: SUB_INVESTIGATOR, contacts name: Alessandro Mannucci, role: SUB_INVESTIGATOR, contacts name: James Lin, role: SUB_INVESTIGATOR, contacts name: Gregory Idos, role: SUB_INVESTIGATOR, contacts name: Trilokesh Kadambi, role: SUB_INVESTIGATOR, geoPoint lat: 34.14806, lon: -117.99895, locations facility: University of California San Diego, status: RECRUITING, city: San Diego, state: California, zip: 92093, country: United States, contacts name: C Richard Boland, MD, PhD, role: CONTACT, contacts name: C Richard Boland, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, locations facility: The First Affiliated Hospital of Dalian Medical University, status: RECRUITING, city: Dalian, country: China, contacts name: Jing Zhang, role: CONTACT, contacts name: Jing Zhang, role: SUB_INVESTIGATOR, contacts name: Caiming Xu, role: SUB_INVESTIGATOR, geoPoint lat: 38.91222, lon: 121.60222, 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: Giulia Martina Cavestro, role: SUB_INVESTIGATOR, contacts name: Alessandro Mannucci, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Mie University, status: RECRUITING, city: Mie, country: Japan, contacts name: Yuji Toiyama, role: CONTACT, contacts name: Yuji Toiyama, role: SUB_INVESTIGATOR, contacts name: Yoshinaga Okugawa, role: SUB_INVESTIGATOR, contacts name: Tadanobu Shimura, role: SUB_INVESTIGATOR, locations facility: Barcelona University, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Francesc Balaguer, MD, PhD, role: CONTACT, email: fprunes@clinic.cat, contacts name: Francesc Balaguer, role: SUB_INVESTIGATOR, contacts name: Miguel Pera, role: SUB_INVESTIGATOR, contacts name: Lorena Moreno, role: SUB_INVESTIGATOR, contacts name: Luis Bujanda, role: SUB_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False