Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-01-01 @ 7:58 PM
Study NCT ID:
NCT04947995
Status:
UNKNOWN
Last Update Posted:
2021-07-01
First Post:
2021-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Omics Noninvasive Inspection of TumOr Risk for Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-24', 'studyFirstSubmitDate': '2021-06-24', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sensitivity and specificity of blood-based multi-omics assay for early detection of gastric cancer with comparison to EGD and/or histological diagnosis.', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective, case-control study intended to develop and validate a blood-based multi-omics assay and computational model for early detection of gastric cancer. Approximately 450 subjects who receive esophageogastroscopy (EGD) will be enrolled and assigned to three arms including gastric cancer, precancerous lesion, and healthy control based on the diagnosis of EGD and histological results. Cell free DNA will be extracted from peripheral blood of all participants and assayed by next-generation sequencing for biomarkers including somatic mutation, methylation, and chromosome instability signals. In the first stage a multi-omics models will be developed for classification between malignancy group and control groups, and between precancerous group and healthy control. Sensitivity and specificity of the model will be evaluated in an independent validation group in the second stage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects aged≥40 who will receive EGD.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age≥40\n* Received EGD;\n* Subjects must have given written informed consent, and the subjects compliance are good.\n\nExclusion Criteria:\n\n* Subjects who could not accept EGD;\n* Subjects who had previously undergone total or partial gastrectomy;\n* There are other serious acute or chronic medical or mental diseases or laboratory abnormalities that may interfere with the interpretation of the research results and make the subjects unsuitable for the study in the judgment of the researchers;\n* Subjects with a history of malignant tumor or two or more malignant tumors at the same time;\n* Pregnant subjects;\n* Subjects who had a history of bone marrow or organ transplantation, or had a history of blood transfusion one month before enrollment.\n* The subjects with incomplete clinical data collection or other reasons judged by the researchers are not suitable for this study.'}, 'identificationModule': {'nctId': 'NCT04947995', 'acronym': 'MONITOR- GAC', 'briefTitle': 'Multi-Omics Noninvasive Inspection of TumOr Risk for Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'GeneCast Biotechnology Co., Ltd.'}, 'officialTitle': 'Validation of a Plasma-based Multiomics Assay and Risk Scoring Model for Screening of Gastric Malignancies', 'orgStudyIdInfo': {'id': 'D-P200110-MCCGW-HP-GC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastric cancer group', 'interventionNames': ['Device: ctDNA multi-omics test']}, {'label': 'Precancerous lesion group', 'interventionNames': ['Device: ctDNA multi-omics test']}, {'label': 'Healthy group', 'interventionNames': ['Device: ctDNA multi-omics test']}], 'interventions': [{'name': 'ctDNA multi-omics test', 'type': 'DEVICE', 'description': 'The ctDNA multi-omics test for gastric cancer will be built based on low-pass WGS, methylation, and target region sequencing.', 'armGroupLabels': ['Gastric cancer group', 'Healthy group', 'Precancerous lesion group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Yao', 'role': 'CONTACT', 'email': 'yaofang99@sina.com', 'phone': '13511073309'}], 'facility': 'Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ning Shen', 'role': 'CONTACT', 'email': 'shen.ning1@genecast.com.cn', 'phone': '400-080-0660'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GeneCast Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}