Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT04618432
Status:
TERMINATED
Last Update Posted:
2023-06-13
First Post:
2020-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'PI moved institutes in NIH, and this protocol was redundant with an existing clinical protocol within the new institute.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2020-11-05', 'studyFirstSubmitQcDate': '2020-11-05', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation for clinical studies', 'timeFrame': 'ongoing', 'description': 'To evaluate patients to determine candidacy for intramural clinical studies'}, {'measure': 'Clinical data collection', 'timeFrame': 'ongoing', 'description': 'To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carcinoma', 'Hearing', 'Balance', 'Neoplasm', 'Natural History'], 'conditions': ['Head and Neck Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_000077-DC.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Study Description:\n\nIt may be in the interest of the NIDCD Clinical Research Program (CRP) to collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders and to evaluate patients to determine candidacy for intramural clinical studies. This protocol will provide the administrative vehicle to enable the evaluation and provision of clinical care for patients with head and neck and communication disorders by the NIDCD CRP, Clinical Center, and consult services. No investigational therapies will be administered in this\n\nstudy.\n\nObjectives and Endpoints:\n\n(Summation)To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders\n\n(Summation)To evaluate patients to determine candidacy for intramural clinical studies\n\nStudy Population:\n\nPatients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder referred to NIDCD Clinical Investigators by the Intramural Consult Service or community providers\n\nDescription of Sites:\n\nNIH Clinical Center\n\nStudy Duration:\n\n10 years', 'detailedDescription': 'Study Description:\n\nIt may be in the interest of the NIDCD Clinical Research Program (CRP) to collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders and to evaluate patients to determine candidacy for intramural clinical studies. This protocol will provide the administrative vehicle to enable the evaluation and provision of clinical care for patients with head and neck and communication disorders by the NIDCD CRP, Clinical Center, and consult services. No investigational therapies will be administered in this\n\nstudy.\n\nObjectives and Endpoints:\n\n(Summation)To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders\n\n(Summation)To evaluate patients to determine candidacy for intramural clinical studies\n\nStudy Population:\n\nPatients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder referred to NIDCD Clinical Investigators by the Intramural Consult Service or community providers\n\nDescription of Sites:\n\nNIH Clinical Center\n\nStudy Duration:\n\n10 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder referred to NIDCD Clinical Investigators by the Intramural Consult Service or community providers', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n* Patients must be age 2 years or older if procedures or treatment are required.\n* Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder.\n* An NIDCD clinical investigator and PI determines it is in the interest of the patient/individual and NIDCD CRP for the subject to undergo consult, treatment or follow-up at the NIDCD/NIH\n* Patient or their Legally Authorized Representative is able to provide informed consent.\n\nEXCLUSION CRITERIA:\n\n* Candidates who do not meet the inclusion criteria.\n* Candidates who in the opinion of the PI and clinical team have medical or unstable conditions for which NIDCD and CC consultative services are unable to provide or support optimal care'}, 'identificationModule': {'nctId': 'NCT04618432', 'briefTitle': 'Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders', 'orgStudyIdInfo': {'id': '10000077'}, 'secondaryIdInfos': [{'id': '000077-DC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Clint T Allen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute on Deafness and Other Communication Disorders (NIDCD)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}