Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-01 @ 8:33 AM
Study NCT ID:
NCT04920435
Status:
COMPLETED
Last Update Posted:
2021-12-07
First Post:
2021-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of the Response to Neoadjuvant Radiation Chemotherapy Through Texture Analysis Derived From Medical Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2021-06-03', 'lastUpdatePostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediction of the complete response (pCR) to neoadjuvant chemoradiotherapy', 'timeFrame': 'TO = Immediately after biopsy and extension evaluation.', 'description': 'defined as the absence of tumor residue on the surgical specimen, ypT0N0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['locally advanced rectal cancer', 'radiomic'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'In patient with complete pathological response, surgery could be omitted without compromising progression-free or overall survival. A powerful prediction model is needed to guide management of this population.\n\nRadiomics features provide complementary information about tumor heterogenity.\n\nThe aim of the investigators is to develop a model combining clinical and radiomic criteria able to predict complete pathological response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with locally advanced rectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* locally advanced rectal cancer\n* patients who received concomitant radio-chemotherapy followed by surgery\n* pre-therapeutic MRI and CT-scan dicom available\n\nExclusion Criteria:\n\n* age under 18 yo\n* lack of MRI or CT-scan'}, 'identificationModule': {'nctId': 'NCT04920435', 'acronym': 'RECTOMICS', 'briefTitle': 'Prediction of the Response to Neoadjuvant Radiation Chemotherapy Through Texture Analysis Derived From Medical Imaging', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Prediction of the Response to Neoadjuvant Radiation Chemotherapy Through Texture Analysis Derived From Magnetic Resonance Imaging, Contrast Injection Computed Tomography and Positron Emission Tomography at 18-FDG in Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': 'RECTOMICS (29BRC20.0027)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'training population', 'description': 'patients from which we will develop the prediction model'}, {'label': 'testing population', 'description': 'patients on whom we will test the prediction model'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29000', 'city': 'Quimper', 'state': 'Brittany Region', 'country': 'France', 'facility': 'Centre Hospitalier de Cornouaille', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'zip': '44800', 'city': 'Nantes', 'state': 'Saint Herblain', 'country': 'France', 'facility': 'ICO', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest (Morvan)', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning one year and ending five years following the publication', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}