Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-28 @ 7:46 PM
Study NCT ID:
NCT06319404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Function of Colorectal Cancer Lymph Nodes
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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the difference of immune pathway activation in tumor-draining lymph node based on genomics', 'timeFrame': '2024.04-2026.04', 'description': 'BULK-RNA sequencing was performed on tumor draining lymph nodes to detect the activation of immune pathways in lymph nodes and explore the differences between them'}, {'measure': 'To investigate the relationship between the type and number of immune cells in tumor draining lymph nodes and the activation of immune pathways is based on pathomics', 'timeFrame': '2024.04-2026.04', 'description': 'Multiple immunohistochemistry was used to identify the type and number of immune cells and to explore the relationship between the activation state of immune pathways'}, {'measure': 'The immune function of tumor draining lymph nodes of colorectal cancer patients was previously identified based on radiomics', 'timeFrame': '2024.04-2026.04', 'description': 'Preoperative imaging data (CT, MRI) of patients were collected, and information in the images was extracted based on artificial intelligence algorithms. Predictive models were constructed to identify patients with good or bad immune function before surgery and guide subsequent treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Lymph Node']}, 'descriptionModule': {'briefSummary': 'Lymph nodes are very important immune organs in the human body and play an important role in the physiological and pathological activities of the body, especially in anti-tumor immunity. The role of regional draining lymph nodes in the development of colorectal cancer is still unknown. In this study, the role of lymph nodes in the development of colorectal cancer was investigated through multicenter and multi-omics data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Stage I-III colorectal cancer patients undergoing radical surgery with complete clinical imaging, pathology, and genetic data.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage I-III colorectal cancer patients undergoing radical surgery\n* Complete imaging, pathology and genetics multi-omics data available\n* 18-75 years old\n\nExclusion Criteria:\n\n* Patients with preoperative neoadjuvant therapy\n* Patients with incomplete clinical information\n* Patients with other malignant tumors\n* Patients with acute infections or untreated chronic infections'}, 'identificationModule': {'nctId': 'NCT06319404', 'briefTitle': 'Immune Function of Colorectal Cancer Lymph Nodes', 'organization': {'class': 'OTHER', 'fullName': 'Shanxi Province Cancer Hospital'}, 'officialTitle': 'A Multiomics-based Study of the Immune Function of Colorectal Cancer Lymph Nodes', 'orgStudyIdInfo': {'id': '2022YFC2505700'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'negative lymph node'}, {'label': 'postive lymph node'}], 'interventions': [{'type': 'OTHER', 'armGroupLabels': ['negative lymph node', 'postive lymph node']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xu Guan', 'role': 'CONTACT', 'email': 'drguanxu@163.com', 'phone': '13141307719'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanxi Province Cancer Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Second Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}