Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05816902
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2023-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AI Prediction Model and Risk Stratification for Lung Metastasis in 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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2779}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-05', 'studyFirstSubmitDate': '2023-04-05', 'studyFirstSubmitQcDate': '2023-04-05', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lung metastasis', 'timeFrame': 'through study completion, an average of 3 month', 'description': 'diagnosed with lung metastasis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Lung Metastases']}, 'descriptionModule': {'briefSummary': 'Background:\n\nTo assist clinicians with diagnosis and optimal treatment decision-making, we attempted to develop and validate an artificial intelligence prediction model for lung metastasis (LM) in colorectal cancer (CRC) patients.\n\nMethod:\n\nThe clinicopathological characteristics of 46037 CRC patients from the Surveillance, Epidemiology, and End Results (SEER) database and 2779 CRC patients from a multi-center external validation set were collected retrospectively. After feature selection by univariate and multivariate analyses, six machine learning (ML) models, including logistic regression, K-nearest neighbor, support vector machine, decision tree, random forest, and balanced random forest (BRF), were developed and validated for the LM prediction. The optimization model with best performance was compared to the clinical predictor. In addition, stratified LM patients by risk score were utilized for survival analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with pathologic confirmation of a primary CRC diagnosis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with pathologic confirmation of a primary CRC diagnosis\n\nExclusion Criteria:\n\n* (1) patients with multiple primary cancers or other malignancies; (2) patients identified via autopsy or death certificate; and (3) patients with uncertain clinical data values'}, 'identificationModule': {'nctId': 'NCT05816902', 'briefTitle': 'AI Prediction Model and Risk Stratification for Lung Metastasis in Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College'}, 'officialTitle': 'Development and Validation of an Artificial Intelligence Prediction Model and a Survival Risk Stratification for Lung Metastasis in Colorectal Cancer From Highly Imbalanced Data', 'orgStudyIdInfo': {'id': 'PekingUMC02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'validation set 1', 'description': 'The validation set 1 was comprised of patients with CRC diagnosed and treated between January 1, 2016, and December 31, 2020, at the Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College.', 'interventionNames': ["Other: The location of the patient's treatment"]}, {'label': 'validation set 2', 'description': 'The validation set 2 was comprised of patients with CRC diagnosed and treated between January 1, 2016, and December 31, 2020, at the Second Affiliated Hospital of Harbin Medical University.', 'interventionNames': ["Other: The location of the patient's treatment"]}], 'interventions': [{'name': "The location of the patient's treatment", 'type': 'OTHER', 'description': "The location of the patient's treatment", 'armGroupLabels': ['validation set 1', 'validation set 2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Second Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'the Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College', 'investigatorFullName': 'Xishan Wang', 'investigatorAffiliation': 'Peking Union Medical College'}}}}