Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT06495827
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predicting Response to Chemotherapy in Colorectal Cancer Via Multi-dimensional Analyses of the Tumor Associated Neutrophils
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 653}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2024-07-03', 'studyFirstSubmitQcDate': '2024-07-10', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months', 'description': 'From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tumor Associated Neutrophils']}, 'descriptionModule': {'briefSummary': 'A single biomarker is not adequate to identify patients with colorectal cancer (CRC) who have the potential to benefit from adjuvant therapy, presumably owing to the complexity of tumor-infiltrating immune cells (TIICs). The density and spatial organization of TIICs has not been definitely established to explore their predictive value. This study aimed to investigate the prognostic significance of TIICs and its biological predictive value in CRC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study enrolled multiple cohorts, consisting of 653 tumor microarray specimens of CRC patients from Zhongshan Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntarily sign a written ICF.\n2. The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.\n3. The expected survival period is ≥ 3 months.\n\n5\\. Subjects diagnosed with metastatic colorectal adenocarcinoma by histology or cytology.\n\n6\\. Colorectal cancer patients who have not received systematic anti-tumor therapy in the past.\n\nExclusion Criteria:\n\n1. Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).\n2. Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.\n3. Received systematic anti-tumor therapy (chemotherapy) within 3 weeks prior to the first administration'}, 'identificationModule': {'nctId': 'NCT06495827', 'briefTitle': 'Predicting Response to Chemotherapy in Colorectal Cancer Via Multi-dimensional Analyses of the Tumor Associated Neutrophils', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Zhongshan Hospital，Fudan University', 'orgStudyIdInfo': {'id': 'TANs for CT response in CRC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'response cohort', 'description': 'CRC patients with response status after chemotherapy', 'interventionNames': ['Other: No different intenvention']}, {'label': 'resistance cohort', 'description': 'CRC patients with resistance status after chemotherapy', 'interventionNames': ['Other: No different intenvention']}], 'interventions': [{'name': 'No different intenvention', 'type': 'OTHER', 'description': 'No different intenvention', 'armGroupLabels': ['resistance cohort', 'response cohort']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of colorectal surgery department, Principal Investigator, Clinical Professor, Zhongshan Hospital', 'investigatorFullName': 'Xu jianmin', 'investigatorAffiliation': 'Fudan University'}}}}