Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-27 @ 7:56 AM
Study NCT ID:
NCT07063550
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-14
First Post:
2025-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microplastics in Paraneoplastic and Intratumoral for Colorectal Cancer
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2025-07-03', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'genomics', 'timeFrame': 'Blood specimens were obtained within one week prior to surgery.', 'description': 'Genomics was tested by preoperative blood specimens.'}], 'secondaryOutcomes': [{'measure': 'metabolomics', 'timeFrame': 'Blood specimens were obtained within one week prior to surgery.', 'description': 'Metabolomics was tested by preoperative blood specimens.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'microplastic', 'Paraneoplastic', 'Genomics', 'Metabolomics'], 'conditions': ['Colorectal Cancer (MSI-H)', 'Microplastic Exposure']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to identify and characterize microplastics present in peritumoral and intratumoral tissues of colorectal cancer patients, and to investigate their associations with gut microbiome composition and metabolic profiles. By integrating microplastic analysis with metagenomic and metabolomic data, we aim to explore the potential impact of environmental microplastic exposure on tumor microenvironment alterations, microbial dysbiosis, and metabolic reprogramming in colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients diagnosed with colorectal cancer and received rectal cancer surgery', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients (≥18 years old) with histologically confirmed colorectal adenocarcinoma.\n* Undergoing elective radical colorectal cancer resection at the study hospital.\n* No prior chemotherapy, radiotherapy, or targeted therapy before surgery.\n* Availability of both tumor tissue and adjacent normal (peritumoral) tissue samples during surgery.\n* Willingness to provide stool and/or blood samples for metagenomic and metabolomic analysis.\n* Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with a history of other malignancies within the past 5 years.\n* Emergency surgery due to obstruction, perforation, or bleeding.\n* Inadequate sample quality or volume for microplastic, metagenomic, or metabolomic analysis.\n* Presence of chronic inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).\n* Use of antibiotics, probiotics, or prebiotics within 4 weeks prior to sample collection.\n* Pregnant or breastfeeding women.\n* Refusal or inability to provide informed consent."}, 'identificationModule': {'nctId': 'NCT07063550', 'briefTitle': 'Microplastics in Paraneoplastic and Intratumoral for Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Identification of Paraneoplastic and Intratumoral Microplastics in Colorectal Cancer and Their Association Analysis With Macrogenomics and Metabolomics', 'orgStudyIdInfo': {'id': '2024-531-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the colorectal cancer group', 'description': 'patients diagnosed with colorectal cancer', 'interventionNames': ['Other: exposure to microplastic']}], 'interventions': [{'name': 'exposure to microplastic', 'type': 'OTHER', 'description': 'Microplastic content in cancerous and paracancerous tissues', 'armGroupLabels': ['the colorectal cancer group']}]}, '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': 'Due to the requirements of the Ethics Committee, it was not permitted to make the acquired data public.'}, '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'}}}}