Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 6:12 PM
Study NCT ID:
NCT06258434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liquid Biopsy Based Multiomics Study for Colorectal Cancer Early Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D018256', 'term': 'Adenomatous Polyps'}, {'id': 'D000236', 'term': 'Adenoma'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055088', 'term': 'Early Detection of Cancer'}], 'ancestors': [{'id': 'D042241', 'term': 'Early Diagnosis'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood and stool sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2024-02-06', 'studyFirstSubmitQcDate': '2024-02-06', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of the multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo) with comparison to colonoscopy', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The Reduced representation bisulfite sequencing (RRBS) technology to obtain multidimensional variation information on cell-free DNA (cfDNA) methylation, end sequence, fragment size distribution, and copy number variation in the blood, and integrate analysis through machine learning algorithms to accurately assess the risk of colorectal cancer and advanced adenoma. The tests were processed independently of colonoscopy procedure, which was blind to investigators who perform the multiomics profiling and integrate data analysis.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of the multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo) with comparison to FIT, with respect to advanced adenoma (AA) and CRC', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The the multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo) and FIT test were performed on the blood and stool sample of the same patient.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Adenomatous Polyps', 'Adenoma', 'Advanced Adenoma']}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine the diagnostic sensitivity and specificity of the newly developed liquid biopsy based multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo) for detecting advanced neoplasia (including colorectal cancer and advanced adenomas) in high risk patients and patients with confirmed CRC, using colonoscopy as the reference method. The secondary objective is to compare the screening performance of the multiomics Colorectal Cancer (CRC) screening test with commercially available FIT (Fecal Immunochemical Test) assay in detecting advanced neoplasia.', 'detailedDescription': 'The study will be carried out in 5 hospitals throughout China. Patients who are at high risk of developing CRC or confirmed CRC and willing to conduct colonoscopy examination will be asked to collect blood prior to bowl preparation for multiomics CRC screening test which using Reduced Representation Bisulfite Sequencing (RRBS) technology to obtain multidimensional variation information on cell-free DNA (cfDNA) methylation, end sequence, fragment size distribution, and copy number variation in the blood, and integrate analysis through machine learning algorithms to accurately assess the risk of colorectal cancer and advanced adenoma. and will be asked to collect stool sample for commercially available FIT assay. Colonoscopy and histopathologic examination are used as reference. The diagnosis information of each sample was blind to the participants who conduct the multiomics profiling, as well as the informatics who perform the integrate analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with high risk of developing CRC and CRC patients', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nWilling to provide written consent Able to provide blood and stool samples\n\nFor high risk CRC screening group:\n\nScheduled for colonoscopy voluntarily or by physician prescription\n\nCRC high risk profile as defined below:\n\nHistory of FIT positivity Family history of CRC Any of two of the following clinical symptoms: chronic constipation/diarrhea, stool with mucous, chronic appendicitis, chronic bilary track diseases, mental stress\n\nFor CRC group:\n\nConfirmed CRC patients No prior treatment with chemotherapy, radiotherapy, and prior to any surgical procedures\n\nExclusion Criteria:\n\nUnwilling to provide blood samples FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis Prior history of colonoscopy within the past 5 years and removal of lesions History of CRC other conditions deemed not suited for the study by investigators"}, 'identificationModule': {'nctId': 'NCT06258434', 'acronym': 'COLO-LIMULOID', 'briefTitle': 'Liquid Biopsy Based Multiomics Study for Colorectal Cancer Early Screening', 'organization': {'class': 'OTHER', 'fullName': 'Sir Run Run Shaw Hospital'}, 'officialTitle': 'Liquid Biopsy Based Multiomics Study for the Detection of Colorectal Advanced Neoplasia in High Risk Chinese Patients: an Prospective, Single Bind Observational Study (COLO-LIMULOID)', 'orgStudyIdInfo': {'id': '20211204-31'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'high risk CRC screening group', 'description': 'Prospective enrollment of subjects with pre-defined high risk factors for developing colorectal cancer or CRC patients', 'interventionNames': ['Diagnostic Test: multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo)']}, {'label': 'CRC group', 'description': 'Prospective enrollment of subjects with confirmed colorectal cancer', 'interventionNames': ['Diagnostic Test: multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo)']}], 'interventions': [{'name': 'multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['fecal immunochemical test（FIT ）', 'diagnostic colonoscopy'], 'description': 'Patients who are at high risk of developing CRC or confirmed CRC and willing to conduct colonoscopy examination will be asked to collect blood prior to bowl preparation for multiomics CRC screening test which using Reduced Representation Bisulfite Sequencing (RRBS) technology to obtain multidimensional variation information on cell-free DNA (cfDNA) methylation, end sequence, fragment size distribution, and copy number variation in the blood, and integrate analysis through machine learning algorithms to accurately assess the risk of colorectal cancer and advanced adenoma. and will be asked to collect stool sample for commercially available FIT assay. Colonoscopy and histopathologic examination are used as reference. The diagnosis information of each sample was blind to the participants who conduct the multiomics profiling, as well as the informatics who perform the integrate analysis.', 'armGroupLabels': ['CRC group', 'high risk CRC screening group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310016', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'sheng dai, MD&PhD', 'role': 'CONTACT', 'email': 'daimd@zju.edu.cn', 'phone': '13575472669'}], 'overallOfficials': [{'name': 'sheng dai, MD&PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sir Run Run Shaw Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, head of medical affairs', 'investigatorFullName': 'Sheng Dai', 'investigatorAffiliation': 'Sir Run Run Shaw Hospital'}}}}