Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-02 @ 4:56 PM
Study NCT ID:
NCT03787667
Status:
UNKNOWN
Last Update Posted:
2018-12-26
First Post:
2018-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of 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': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-22', 'studyFirstSubmitDate': '2018-12-22', 'studyFirstSubmitQcDate': '2018-12-22', 'lastUpdatePostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': '2 years', 'description': 'The sensitivity of radiomics in predicting regional or distant synchronous colorectal metastasis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer Stage I-IV']}, 'descriptionModule': {'briefSummary': 'This is a prospective, clinical study. This study is to collect and analyze data of radiomics of primary site or metastasis of colorectal cancer aiming to precisizing preoperative diagnosis and long-term prognsis evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients received enhaced CT or MRI test must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with pathologically confirmed colorectal cancer\n* Male or female aged 18-75 years old on the day of signing informed consent.\n* Patients who received imageological examination of primary or metastasis\n* Patients who received surgical resection of primary or metastasis\n* Patients must have a performance status of ≤1 on the ECOG Performance Scale.\n* Colorectal cancer is the only malignant tumor\n* Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Patients received adjuvant treatment prior to imageological examination\n* Tis stage patients\n* Paitents who diagnosed with malignant disease within 5 years.\n* Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator."}, 'identificationModule': {'nctId': 'NCT03787667', 'briefTitle': 'Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer: a Prospective, Clinical Study', 'orgStudyIdInfo': {'id': 'ColoRadiomics'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with pathologically diagnosed colorectal cancer', 'description': 'Patients with pathologically diagnosed colorectal cancer', 'interventionNames': ['Diagnostic Test: CT or MRI based Radiomics']}], 'interventions': [{'name': 'CT or MRI based Radiomics', 'type': 'DIAGNOSTIC_TEST', 'description': 'Radiomic features were extracted from enhanced CT or MRI of colorectal cancer.', 'armGroupLabels': ['Patients with pathologically diagnosed colorectal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guoxiang Cai', 'role': 'CONTACT', 'email': 'gxcai@fudan.edu.cn', 'phone': '+8613611831623', 'phoneExt': '+8613611831623'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Guoxiang Cai, M.D.Ph.D.', 'role': 'CONTACT', 'email': 'gxcai@fudan.edu.cn', 'phone': '+86 13611831623'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Guoxiang Cai', 'investigatorAffiliation': 'Fudan University'}}}}