Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-04 @ 8:44 PM
Study NCT ID:
NCT02486094
Status:
COMPLETED
Last Update Posted:
2017-06-12
First Post:
2015-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of PRoliferation and Apoptosis in Rectal Cancer, Predictive & Prognostic biOmarkers: Histopathology and Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Pre-treatment biopsy and post surgical tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-09', 'studyFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2015-06-26', 'lastUpdatePostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apoptotic index, Ki67 and Geminin in cells per mm cubed from diognostic biopsy', 'timeFrame': 'Tissue removed at diagnosis (approximately 15 weeks prior to surgery)', 'description': 'Tissue biopsy taken at endoscopy to confirm cancer diagnosis is studied'}, {'measure': 'Apoptotic index, Ki67 and Geminin in cells per mm cubed from resected tumour', 'timeFrame': 'Tissue removed during operation', 'description': 'Tissue removed during surgery (to resect tumour) is studied'}], 'secondaryOutcomes': [{'measure': 'Time to local recurrence', 'timeFrame': 'At one and three years'}, {'measure': 'Disease Free Survival (DFS)', 'timeFrame': 'At one and three years'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'At one and three years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Imaging, Magnetic Resonance', 'Rectal Cancer', 'Apoptosis', 'Proliferation', 'Cancer', 'Tissue Study'], 'conditions': ['Neoplasms', 'Colorectal Neoplasms', 'Rectal Diseases', 'Gastrointestinal Neoplasms']}, 'descriptionModule': {'briefSummary': 'This study tests biopsy and tissue from patients who have been treated for primary rectal cancer at the Royal Marsden Hospital between 2011 and 2013, who have an mrTRG score at post-chemoradiotherapy MRI. It is a retrospective pilot study to determine the apoptotic and proliferative index count pre and post chemoradiotherapy.', 'detailedDescription': 'The investigators hope to validate the apoptotic and proliferative index as a predictive response marker and lend support to mrTRG as a putative prognostic tool in the treatment pathway for rectal cancer patients. Even though this is a retrospective study, the investigators hope that pre-treatment apoptotic and proliferative scores will correlate to post treatment response and mrTRG scores. In doing so, the investigators can predict how patients will respond to treatment from initial diagnostic biopsies and foresee a patients individual treatment plan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with rectal cancer, diagnosed between 2011 and 2013, who have had an mrTRG score in a post-radiotherapy MRI scan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age.\n* Patients with primary adenocarcinoma of the rectum (diagnosed on tissue biopsy and disease spread assessed on CT and MRI).\n* Tumours must be considered sufficiently high-risk to require pre-operative chemoradiotherapy followed by surgery.\n* Patients must have had a pre- and post-treatment MRI scan of the rectum and pelvis.\n* We must have access to stored tissue for each patient\n\nExclusion Criteria:\n\n* No pre-operative radiotherapy\n* Patients with synchronous tumours\n* Patients under the age of 18 years'}, 'identificationModule': {'nctId': 'NCT02486094', 'acronym': 'SOPRANO', 'briefTitle': 'Study of PRoliferation and Apoptosis in Rectal Cancer, Predictive & Prognostic biOmarkers: Histopathology and Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'Study Of PRoliferation and Apoptosis in Rectal caNcer as Predictive and Prognostic biOmarkers: a Histopathology and Imaging Analysis', 'orgStudyIdInfo': {'id': 'CCR 4324'}}, 'contactsLocationsModule': {'locations': [{'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Gina Brown', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden Hospital NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Royal College of Surgeons of England', 'class': 'OTHER'}, {'name': 'Croydon Health Services NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}