Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
Study NCT ID:
NCT06852495
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-28
First Post:
2025-02-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
the Effect of Environmental Factors on Colorectal Cancer Based on Macrogenomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Feces'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2025-02-25', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prognosis', 'timeFrame': 'From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months', 'description': 'Overall survival (OS), from date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first.'}], 'secondaryOutcomes': [{'measure': 'Macrogenomic differences', 'timeFrame': 'The date of macrogenomic testing, assessed up to 1 week after surgery.', 'description': 'Macrogenomic differences in feces.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal cancer', 'Macrogenome', 'Environmental pollution', 'air pollution'], 'conditions': ['Colon Cancer', 'Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of environmental factors, such as air pollution, on the occurrence, development and prognosis of colorectal cancer; to identify metabolic markers specific to colorectal cancer patients, which will provide a basis for early diagnosis, early intervention and individualized treatment; and to comprehensively understand the mechanism of the occurrence and development of colorectal cancer by integrating the data of environmental factors and the macro-genome, and to develop new predictive and therapeutic strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with colorectal cancer by pathological biopsy and healthy participants with no history of malignancy were included in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old;\n* Patients diagnosed with colorectal cancer by pathologic biopsy before surgery;\n* Patients did not undergo chemotherapy, radiotherapy, targeted and immunotherapy, etc. before enrollment;\n* Willing to participate in the study and sign an informed consent form. Complete clinical data.\n\nExclusion Criteria:\n\n* Concurrent primary malignant tumor other than colorectal cancer;\n* Patients with severe cardiopulmonary insufficiency or other systemic diseases that affect the choice of treatment plan;\n* Inappropriate for enrollment as assessed by the investigator;\n* Incomplete clinical data.'}, 'identificationModule': {'nctId': 'NCT06852495', 'briefTitle': 'the Effect of Environmental Factors on Colorectal Cancer Based on Macrogenomes', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'A Study of Colorectal Cancer Development and Prognosis Based on Environmental Factors and Macrogenomes', 'orgStudyIdInfo': {'id': '2024-443-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the colorectal cancer group', 'description': 'patients diagnosed with colorectal cancer'}, {'label': 'the control group', 'description': 'Healthy individuals with no history of malignant tumor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data sharing is not permitted by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong Peng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dong Peng', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}