A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers

Launched by YONSEI UNIVERSITY · Jan 21, 2024

Nctid: NCT06231953

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>4000}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2022-10-13", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-21", "studyFirstSubmitDate"=>"2023-05-18", "studyFirstSubmitQcDate"=>"2024-01-21", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value", "timeFrame"=>"36 months"}, {"measure"=>"Accuracy of prediction for the origin of cancer, assessed by concordance rate", "timeFrame"=>"36 months"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Invasive Cancer", "Healthy Volunteer"]}, "descriptionModule"=>{"briefSummary"=>"This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. The purpose of this study is to establish MCED platform through the analysis of whole genome sequencing of circulating DNA.\n\nThe study will enroll 4,000 subjects as defined by eligibility criteria at up to 10 clinical institutions in South Korea.", "detailedDescription"=>"AIMA is analysing whole genome sequencing data of circulating tumor DNA, combined through machine learning technique, to develop MCED platform to detect early stage cancer.\n\nThe purpose of this prospective, multi-center, observational study is to validate an MCED platform for the early detection of cancers.\n\nThe investigators will collect blood samples from subjects who are diagnosed as invasive cancers before treatment or from healthy volunteers."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"19 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Subjects who have diagnosed invasive cancer or healthy volunteers", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Aged 19 years or older\n* Subjects who have been diagnosed with stages 1 to 4 of solid tumor or healthy volunteers who have scheduled a cancer screening examination\n* Subjects who have agreed to provide clinical information and blood samples\n* Subjects who have agreed for the storage and secondary use of residual blood samples for research\n* Subjects who have understood the study and are able to provide a written informed consent\n\nExclusion Criteria:\n\n* Subjects who are not appropriate for the study because of intellectual disabilities or severe mental disorders\n* Subjects with a history of HIV, HTLV, or Syphilis infection\n* Subjects with primary site unknown cancer or synchronous or metachronous double primary cancers\n* Subjects who have diagnosed with any other malignant tumor within the past 5 years (except for cured non-melanoma skin cancer, in situ cancer, or thyroid cancer)"}, "identificationModule"=>{"nctId"=>"NCT06231953", "briefTitle"=>"A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers", "organization"=>{"class"=>"OTHER", "fullName"=>"Yonsei University"}, "officialTitle"=>"A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers.", "orgStudyIdInfo"=>{"id"=>"4-2022-0299"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Cancer patients", "description"=>"Patients who have diagnosed as invasive cancers"}, {"label"=>"Healthy volunteers", "description"=>"Subjects who have done cancer screening tests"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Seoul", "status"=>"RECRUITING", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"Joohyuk Sohn", "role"=>"CONTACT", "email"=>"oncosohn@yuhs.ac", "phone"=>"+82-2-2228-8135"}], "facility"=>"Yonsei Cancer Center, Yonsei Univ. College of Medicine", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}], "centralContacts"=>[{"name"=>"Joohyuk Sohn", "role"=>"CONTACT", "email"=>"oncosohn@yuhs.ac", "phone"=>"+82-2-2228-8135"}], "overallOfficials"=>[{"name"=>"Joohyuk Sohn", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Yonsei University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}