Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-02-21 @ 4:48 PM
Study NCT ID:
NCT04249895
Status:
COMPLETED
Last Update Posted:
2021-12-17
First Post:
2020-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Digital Archive of Cancer Imaging-Radiation Oncology( CHAVI-RO )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-02', 'studyFirstSubmitDate': '2020-01-29', 'studyFirstSubmitQcDate': '2020-01-29', 'lastUpdatePostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with complete data safe.', 'timeFrame': '18 months', 'description': 'Count of patients with complete radiological, pathological and demographic information in the CHAVI RO database.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carcinoma', 'Radiomics', 'Image Processing', 'Radiology', 'Molecular Biology', 'Data Analytics Center', 'Artificial Intelligence', 'Medical Physics', 'Big Data', 'Radiation Oncology'], 'conditions': ['All Cancer']}, 'descriptionModule': {'briefSummary': "In this pilot project Investigators propose to create annotated image data bank of patients suffering from cancer. The system will provide India's first comprehensive platform to upload annotated images with associated medical and demographic information of a patient. It will support flexible query from the users with appropriate choice from a set of attributes and design of various query filters using a GUI. Over the proposed period of 18 months, images and records related to radiation oncology including pretreatment images of at least 500 patients would be annotated and archived in the data bank. The imaging modalities to be covered are X-RAY mammograms, SPECT, CT, CBCT, MR, PET-CT, Ultrasound, digital histopathology, etc. In this phase, this study will include data sets of five types of cancers namely, breast, head and neck, brain, cervix and lung cancer.\n\nInvestigator propose to demonstrate the application of this data set in cancer research. Investigator will work on serial PET-CT based radiomics of breast and cervix cancer patients to extract appropriate features and correlate them with clinico-pathological variants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Patients undergoing radiotherapy in the dept of radiotherapy, Tata Medical Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Patients undergoing radiotherapy planned with volumetric imaging.\n\n\\-\n\nExclusion Criteria:\n\n* Informed Consent not given'}, 'identificationModule': {'nctId': 'NCT04249895', 'briefTitle': 'Comprehensive Digital Archive of Cancer Imaging-Radiation Oncology( CHAVI-RO )', 'organization': {'class': 'OTHER', 'fullName': 'Tata Medical Center'}, 'officialTitle': 'Comprehensive Digital Archive of Cancer Imaging-Radiation Oncology( CHAVI-RO )', 'orgStudyIdInfo': {'id': 'EC/GOVT/24/IRB23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Main Cohort', 'description': 'All patients are undergoing radiotherapy in Tata Medical Center'}]}, 'contactsLocationsModule': {'locations': [{'zip': '700160', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Sanjoy Chatterjee', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tata Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}