Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-26 @ 12:48 PM
Study NCT ID:
NCT03877159
Status:
UNKNOWN
Last Update Posted:
2020-07-22
First Post:
2019-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-01-23', 'releaseDate': '2023-05-04'}], 'estimatedResultsFirstSubmitDate': '2023-05-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-03-14', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caspase-8 activity in oral cancer and its impact on disease progression', 'timeFrame': 'Up to 3 years', 'description': 'Molecular analysis of caspase-8 activity will be undertaken and correlated with tumour features and outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Oral Cancer']}, 'descriptionModule': {'briefSummary': 'Control of cell death is frequently disrupted in cancer resulting in overgrowth of tumour cells. Caspase-8 is a key enzyme involved in controlling cell death. This study examines the importance of caspase-8 in oral cancer.', 'detailedDescription': 'Control of cell death is frequently disrupted in cancer resulting in overgrowth of tumour cells. The caspase family of enzymes are the key performers of controlled cell death and caspase-8 is frequently mutated in oral cancer. This study will perform DNA sequencing to determine if the gene is wild-type (not mutated). The abundance of inactive (uncleaved) and active (cleaved) caspase-8 will be determined. The levels of the proteins that caspase-8 interacts with (including caspase-3) will be determined. Results will be correlated with tumour stage, patient outcome and the presence of immune cells and other microscopic features. This will improve the understanding of the importance of caspase-8 in oral cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Archived oral cancer tissue specimens within this single institute.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Oral cancer\n* Sufficient follow up data\n\nExclusion Criteria:\n\n* Patient has indicated that they do not wish their tissue to be used for research.\n* . The quantity or quality of tissue is too little or poor to provide adequate material without significant reserve.\n* The material contains bone.'}, 'identificationModule': {'nctId': 'NCT03877159', 'briefTitle': 'Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': '232080'}}, 'armsInterventionsModule': {'interventions': [{'name': 'There is no intervention.', 'type': 'OTHER', 'description': 'There is no intervention. This is a retrospective study analysing archived tumour samples.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE19RT', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Robert Kennedy, BSc PhD BDS', 'role': 'CONTACT'}], 'facility': 'Robert Kennedy', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Robert Kennedy, BSc PhD BDS', 'role': 'CONTACT', 'email': 'robert.kennedy@kcl.ac.uk', 'phone': '07815501088'}], 'overallOfficials': [{'name': 'Robert Kennedy, BSc PhD BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KCL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No patient identifiable data is stored'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-05-04', 'type': 'RELEASE'}, {'date': '2024-01-23', 'type': 'RESET'}], 'unpostedResponsibleParty': "Guy's and St Thomas' NHS Foundation Trust"}}}}