Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT06011694
Status:
RECRUITING
Last Update Posted:
2023-08-25
First Post:
2023-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Jinling Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2027-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2023-08-09', 'studyFirstSubmitQcDate': '2023-08-23', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate sensitivity, specificity, positive/negative predictive value and other performance measures of the multi-omics liquid biopsy test MERCURY for multi-cancer early detection in average risk population', 'timeFrame': 'assessed up to 60 months'}], 'secondaryOutcomes': [{'measure': 'To evaluate how many cancer types the multi-omics liquid biopsy MCED (multi-cancer early detection) test MERCURY can detect and TOO (tumor of origin) accuracy', 'timeFrame': 'assessed up to 60 months', 'description': 'To assess whether the TOO (tumor of origin) results predicted from the multi-omics liquid biopsy MCED (multi-cancer early detection) test MERCURY match with clinical diagnostic tumor types received from follow-up. Summarize the number of consistency and inconsistency to evaluate the prediction accuracy'}, {'measure': "To assess test MERCURY's efficiency and clinical utility in average risk population", 'timeFrame': 'assessed up to 60 months', 'description': "To assess MERCURY test's lead-time relative to clinical diagnosis. With MCED test and routine physical exams being conducted in parallel for three years and following up for five years, the study allows to assess MERCURY test can detect cancer how many years earlier than conventional methods by comparing MERCURY test positive timepoint to tumor clinical diagnosis timepoint."}, {'measure': "To evaluate participants' attitude and perception towards MCED blood test", 'timeFrame': 'assessed up to 60 months', 'description': "To compare the adherence to annual blood exams to reported SOC (standard of care) screening methods to see whether participants' perception towards MCED blood test"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early Detection of Cancer', 'MCED'], 'conditions': ['Cancer', 'Multi Cancer Early Screening', 'Liquid Biopsy']}, 'descriptionModule': {'briefSummary': 'The Jinling Cohort is a prospective, multicenter cohort study in which 15,000 eligible individuals aged 45-75 in Nanjing China will be enrolled.', 'detailedDescription': "Its aim is to assess the performance and clinical utility of the Multi-omics liquid biopsy MCED test MERCURY in an average risk Chinese population. Each participant will undergo peripheral blood collection for MERCURY test, health questionnaires and annual routine physical exams once a year for three consecutive years, then followed up two additional years. The entire assess time is 60 months.\n\nThe primary goals of the study is to evaluate sensitivity, specificity, positive/negative predictive value and other performance of MERCURY test.\n\nThe secondary goal of the study is (1) to evaluate how many cancer types the test MERCURY can detect and TOO accuracy; (2) With MCED test and routine physical exams being conducted in parallel for three years and following up for five years, the study allows to assess MERCURY test can detect cancer how many years earlier than conventional methods, leading to its clinical value evaluation of whether it can ensure reduction in late-stage cancer diagnosis; (3) to evaluate participants' attitude and perception towards MCED blood test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '45 Years to 75 Years (Adult, Older Adult)，Each participant will undergo peripheral blood collection for MERCURY test, health questionnaires and annual routine physical exams once a year for three consecutive years, then followed up two additional years.\n\nNo', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1、45-75 years of age; 2、Willing and able to undergo blood sample collection, health questionnaires and annual routine physical exams once a year for three consecutive years; 3、Residents in Nanjing; 4、Fully understand the study and able to provide a written informed consent\n\nExclusion Criteria:\n\n1. Pregnant women;\n2. Individuals who have history of cancer or current diagnosis of cancer;\n3. Individuals who have organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant;\n4. Individulas who have blood transfusion within 30 days prior to the blood draw;\n5. Individuals who have an acute infection or inflammation within 14 days prior to the blood draw;\n6. Individuals who have taken medication with anti-tumor effects within 30 days prior to the blood draw;\n7. Individuals who will not be able to comply with the protocol procedures judged by researchers'}, 'identificationModule': {'nctId': 'NCT06011694', 'briefTitle': 'The Jinling Cohort', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nanjing Shihejiyin Technology, Inc.'}, 'officialTitle': 'A Prospective, Multicenter Cohort Study of the Multi-omics Liquid Biopsy MCED Test MERCURY in an Average Risk Chinese Population', 'orgStudyIdInfo': {'id': 'NanjingShihejiyinTech'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Intervention', 'description': 'Each participant will undergo peripheral blood collection for MERCURY test, health questionnaires and annual routine physical exams once a year for three consecutive years, then followed up two additional years.', 'interventionNames': ['Other: MERCURY test, health questionnaires and annual routine physical exams']}], 'interventions': [{'name': 'MERCURY test, health questionnaires and annual routine physical exams', 'type': 'OTHER', 'description': 'Each participant will undergo peripheral blood collection for MERCURY test, health questionnaires and annual routine physical exams once a year for three consecutive years, then followed up two additional years.', 'armGroupLabels': ['No Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianbei Huang', 'role': 'CONTACT', 'phone': '+8618951766697'}], 'facility': "Nanjing Jiangbei People's Hospital", 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuan Mao, Ph.D', 'role': 'CONTACT', 'phone': '+8613951918531'}], 'facility': 'The Fourth Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Shanshan Yang, Ph.D', 'role': 'CONTACT', 'email': 'admin@geneseeq.com', 'phone': '8613585145836'}, {'name': 'Xuan Wang', 'role': 'CONTACT', 'email': 'cohortstudy@geneseeq.com', 'phone': '8618392411194'}], 'overallOfficials': [{'name': 'Shao Yang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NanjingShihejiyin Technology Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Shihejiyin Technology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}