Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
Study NCT ID:
NCT04543266
Status:
UNKNOWN
Last Update Posted:
2020-09-11
First Post:
2020-09-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predicting Metastatic Oral Squamous Cell Carcinomas With Molecular Biomarkers Using Machine Learning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Embedded blocks will be used for protein expressions'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-09-08', 'lastUpdatePostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcomes of the study are metastasis and recurrent disease', 'timeFrame': 'Baseline of OSCC', 'description': 'These outcomes will be entered as the dependent variables into the machine learning model'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OSCC; Oral cancer; Machine Learning'], 'conditions': ['Oral Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'Application Management Team:\n\nPI - Siu Wai Choi; email - htswchoi@hku.hk Delegates - Chui Shan Chu; email: sunshine.c@connect.hku.hk FollowUpUsers - Chui Shan Chu; email:sunshine.c@connect.hku.hk', 'detailedDescription': 'Eligibility Criteria:\n\n\\- patients were diagnosed with a baseline disease of oral squamous carcinoma.\n\nExclusion Criteria:\n\n\\- N/A\n\nSample size:\n\n\\- \\~500 subjects\n\nSource of Data:\n\n\\- The data, such as age and medical records, would be obtained from Hospital Authority Clinical Management System (HACMS)\n\nStatistical analysis:\n\n\\- machine learning will be applied into analysis plan'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a retrospective, cohort study of all oral SCC patients who were treated with surgery for their primary oral SCC tumours at Queen Mary Hospital, from 1st October 2000 to 1st October 2019. The investigation will involve retrieval of paraffin embedded tissue blocks, determination of biomarker profile in these tissues, and retrieval of patient data from the Clinical Management System. No new patients will be prospectively recruited into the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with oral squamous carcinoma\n* received surgery from 1st October 2000 to 1st October 2019\n\nExclusion Criteria:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT04543266', 'briefTitle': 'Predicting Metastatic Oral Squamous Cell Carcinomas With Molecular Biomarkers Using Machine Learning', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Predicting Metastatic Oral Squamous Cell Carcinomas With Molecular Biomarkers Using Machine Learning', 'orgStudyIdInfo': {'id': 'UW19-704'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Progressive Disease', 'description': 'Patients with metastasis and/or recurrent OSCC were considered as a group of subjects with progressive disease', 'interventionNames': ['Procedure: Surgery']}, {'label': 'Patients without Progressive Disease', 'description': 'Patients without metastasis and/or recurrent OSCC were considered as a group of subjects without progressive disease', 'interventionNames': ['Procedure: Surgery']}], 'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'otherNames': ['Chemo-radiotherapy'], 'description': 'Resection of tumors', 'armGroupLabels': ['Patients with Progressive Disease', 'Patients without Progressive Disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'SW Choi, PhD', 'role': 'CONTACT', 'email': 'htswchoi@hku.hk'}, {'name': 'Chui Shan Chu, BSc', 'role': 'CONTACT', 'email': 'sunshine.c@connect.hku.hk'}, {'name': 'SW Choi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'SW Choi, PhD', 'role': 'CONTACT', 'email': 'htswchoi@hku.hk', 'phone': '+85228590390'}, {'name': 'Chui Shan Chu, MMedSc', 'role': 'CONTACT', 'email': 'sunshine.c@connect.hku.hk', 'phone': '+85252227292'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Dr. Choi Siu-wai', 'investigatorAffiliation': 'The University of Hong Kong'}}}}