Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-04 @ 10:54 PM
Study NCT ID:
NCT06535867
Status:
RECRUITING
Last Update Posted:
2025-05-22
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Conventional Screening Versus mHealth Screening in Early Detection of Oral Potentially Malignant Disorders and Oral Cancer Amongst the Rural Population of Varanasi: A Prospective and Blinded Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D004327', 'term': 'Drinking Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5122}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2031-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of mHealth with conventional oral cancer screening', 'timeFrame': 'Up to 5 years', 'description': 'To compare the efficacy of conventional screening with mHealth in identification of oral potentially malignant disorders (OPMDs) / oral cancer.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['smoking', 'smoking, cigarette', 'smoking, tobacco', 'smokeless tobacco', 'betel leaf', 'areca nut', 'paan masala', 'alcohol use', 'Memorial Sloan Kettering Cancer Center', '24-148'], 'conditions': ['Smoking', 'Smoking, Cigarette', 'Smoking, Tobacco', "Betel Chewer's Mucosa", 'Tobacco Use', 'Tobacco Smoking', 'Alcohol Drinking', 'Smokeless Tobacco Hyperkeratosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'Mobile health (mHealth) will be used for early detection of oral cancer and pre-cancer lesions, and to improve awareness of oral cancer among the population and knowledge of oral cancer diagnosis among frontline health providers. This program is inclusive of long term surveillance to downstage oral cancer in India'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Field health personnel (FHP) with help of ASHA (a healthcare network in rural areas) will visit household and collect mobile phone numbers in Varanasi.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPositive for any one or more of the following:\n\n* All individuals aged above 18 years positive for habits (smoking and smokeless tobacco, chewing betel leaf, areca nut, paan masala, and/or regular use of alcohol)\n* Clinical signs/symptoms (non-healing ulcers, white/ red/red \\& white patches in the mouth, restriction of mouth opening and swelling of the neck)\n* All individuals aged above 40 irrespective of habit/oral lesions\n\nExclusion Criteria:\n\n* Individuals already diagnosed with oral cancer and undergoing treatment for oral cancer\n* Under treatment for tuberculosis or suffering from any acute illness/ debilitating systemic disorders'}, 'identificationModule': {'nctId': 'NCT06535867', 'briefTitle': 'The Efficacy of Conventional Screening Versus mHealth Screening in Early Detection of Oral Potentially Malignant Disorders and Oral Cancer Amongst the Rural Population of Varanasi: A Prospective and Blinded Study', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'The Efficacy of Conventional Screening Versus mHealth Screening in Early Detection of Oral Potentially Malignant Disorders and Oral Cancer Amongst the Rural Population of Varanasi: A Prospective and Blinded Study', 'orgStudyIdInfo': {'id': '24-148'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants from Varanasi', 'description': 'Participants will be recruited from Varanasi.', 'interventionNames': ['Diagnostic Test: mHealth']}], 'interventions': [{'name': 'mHealth', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Mobile Health'], 'description': 'The mobile health (mHealth) program will be used for early detection of oral cancer and pre-cancer lesions, and to improve awareness of oral cancer among the population and knowledge of oral cancer diagnosis among frontline health providers.', 'armGroupLabels': ['Participants from Varanasi']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Milind Rajadhyaksha, PhD', 'role': 'CONTACT', 'phone': '646-608-2364'}], 'facility': 'Memorial Sloan Kettering Cancer Center (All protocol activites)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Milind Rajadhyaksha, PhD', 'role': 'CONTACT', 'email': 'rajadhym@mskcc.org', 'phone': '646-608-2364'}, {'name': 'Aditi Sahu', 'role': 'CONTACT', 'email': 'sahua@mskcc.org', 'phone': '646-608-1935'}], 'overallOfficials': [{'name': 'Milind Rajadhyaksha, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}