Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-28 @ 10:52 PM
Study NCT ID:
NCT04913233
Status:
UNKNOWN
Last Update Posted:
2021-06-04
First Post:
2021-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishment and Clinical Validation of New Technologies for Accurate Screening of Colorectal Cancer Based on Multi-omics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-30', 'studyFirstSubmitDate': '2021-05-30', 'studyFirstSubmitQcDate': '2021-05-30', 'lastUpdatePostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colorectal cancer detection rate in the population', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Colorectal cancer detection rate in the population'}, {'measure': 'Colorectal cancer screening specificity', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Colorectal cancer screening specificity'}, {'measure': 'Colorectal cancer screening sensitivity', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Colorectal cancer screening sensitivity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal cancer', 'Cancer Screening', 'Colonoscopy', 'APCS', 'HRFQ'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Background:\n\nThe current screening techniques for colorectal cancer include colonoscopy, fecal occult blood, and high-risk factor questionnaires. However, the colorectal cancer screening technology that has been widely used at present cannot take into account sensitivity and specificity, and the tumor detection rate is low.\n\nThe purpose of research:\n\n1. Build a new type of population colorectal cancer precision screening technology program;\n2. Improve the detection rate of colorectal cancer in the population by new methods (compared with the existing domestic advanced technology) by ≥20%, and improve the specificity of colorectal cancer screening by ≥15% without significantly reducing the sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals of 40-74 years old in non-high incidence of colorectal cancer areas(hospital outpatient population, community population in non-high-risk areas) .', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge: 40-74 years old\n\nExclusion Criteria:\n\n1. Combine severe disorders to make it unsuitable for colonoscopy\n2. Combine other tumors\n3. Mental and behavioral abnormalities do not cooperate with the screener\n4. Researchers believe that other reasons are not suitable for enrollment'}, 'identificationModule': {'nctId': 'NCT04913233', 'briefTitle': 'Establishment and Clinical Validation of New Technologies for Accurate Screening of Colorectal Cancer Based on Multi-omics', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Research on New Technologies for Screening and Early Diagnosis of Malignant Tumors - Establishment and Clinical Validation of New Technologies for Accurate Screening of Colorectal Cancer Based on Multi-omics', 'orgStudyIdInfo': {'id': '2021-0199'}}, 'contactsLocationsModule': {'locations': [{'zip': '314400', 'city': 'Haining', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Weihua Ma', 'role': 'CONTACT', 'email': '672682815@qq.com'}], 'facility': 'Chinese Medicine Hospital of Haining City, Haining Cancer Preventional and Treatment Research Institute', 'geoPoint': {'lat': 30.53629, 'lon': 120.68638}}, {'zip': '314100', 'city': 'Jiashan', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Xinglin Fei', 'role': 'CONTACT', 'email': 'feixl711@163.com'}], 'facility': 'Jiashan County Cancer Prevention and Treatment Institute', 'geoPoint': {'lat': 30.84918, 'lon': 120.92583}}, {'zip': '321100', 'city': 'Lanxi', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Weifang Zheng', 'role': 'CONTACT', 'email': '2609276435@qq.com'}], 'facility': "Lanxi City People's Hospital, Linjiang Hospital", 'geoPoint': {'lat': 29.21588, 'lon': 119.47156}}], 'centralContacts': [{'name': 'Ying Yuan', 'role': 'CONTACT', 'email': 'yuanying1999@zju.edu.cn', 'phone': '+8613858193601'}, {'name': 'Yanqin Huang', 'role': 'CONTACT', 'email': '13588418080@163.com', 'phone': '+8613588418080'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}