Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT02147418
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2014-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'All oropharyngeal rinse (gargle) specimens will be processed within 24 hours of collection. Any remaining material after testing will be stored for a period not to exceed 1 year in a secure location.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2014-05-22', 'studyFirstSubmitQcDate': '2014-05-22', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exosome Signatures Oropharyngeal Rinse Measure', 'timeFrame': '1 month', 'description': 'Compare exosome protein signatures generated from cells obtained through oropharyngeal rinses of patients with HPV-positive OPSCC and normal controls to identify an exosome protein marker that is absent (or present at a different, statistically significant level) in the oropharyngeal rinses of normal controls.'}], 'primaryOutcomes': [{'measure': 'Cultured Cell Exosome Protein Signature Outcome Measure', 'timeFrame': '1 month', 'description': 'The presence of unique proteins obtained from primary cell cultures derived from HPV-OPSCC confirmed patients will be compared to normal tonsillar epithelial cells and established cell lines. The distribution of these protein signatures will be compared in HPV-OPSCC and normal epithelial cells.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Head and neck cancer', 'Throat cancer', 'Human papillomavirus', 'HPV', 'Exosome', 'Diagnostic', 'Early Detection'], 'conditions': ['Oropharyngeal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.unm.edu', 'label': 'University of New Mexico Cancer Center'}, {'url': 'http://www.nmcca.org', 'label': 'New Mexico Cancer Care Alliance'}]}, 'descriptionModule': {'briefSummary': 'Cancer of the oropharynx (middle, side and back walls of the throat; back of the tongue; soft palate, and tonsils), or oropharyngeal squamous cell carcinoma (OPSCC), has been on the rise in the United States. Human papillomavirus (HPV) has been recognized in many of these cancers, and testing for HPV has contributed to the higher reported rates of OPSCC. In this study, our goal is to develop a new test that can detect certain HPV proteins in the blood or saliva to help improve detection of OPSCC.', 'detailedDescription': 'While secondary screening strategies have successfully reduced the rate of HPV-positive cervical cancers, an effective screening modality for HPV-OPSCC does not exist. A central problem in the early diagnosis of HPV-OPSCC is the relative inaccessibility of the tonsillar crypts, where oncogenic infections are thought to originate. Unlike the relatively smooth surface of the cervix which permits mechanical sampling with Pap tests and which can be evaluated visually for evidence of dysplasia, much of the tonsillar epithelium is found below the surface in a complex network. As a consequence, any screening modality cannot depend upon direct access to malignant lesions. What is needed is a minimally invasive, diffusible or circulating marker of HPV-OPSCC, and a means to collect and detect it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patient population will consist of adults presenting to the Division of Otolaryngology - Head and Neck Surgery at the University of New Mexico with previously untreated OPSCC. Both HPV-positive and HPV-negative malignancies will be collected as the study and control groups, respectively. In addition, saliva samples will be collected from patients presenting with benign conditions as a further negative control.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Cancer Patients):\n\n* Male or Female\n* Age greater than or equal to 18\n* Previously untreated, pathologically confirmed OPSCC (HPV+ or HPV-)\n* Ability to understand study information and provide written consent for participation.\n\nInclusion Criteria (Non-cancer Patients):\n\n* Male or Female\n* Age greater than or equal to 18\n* Ability to understand study information and provide written consent for participation\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Prisoners\n* Pregnant women\n* Patients with mental disability'}, 'identificationModule': {'nctId': 'NCT02147418', 'briefTitle': 'Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'New Mexico Cancer Research Alliance'}, 'officialTitle': 'An Observational, Single-Institution Pilot/Feasibility Study of Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'INST 1310'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: HPV-positive Cancer', 'description': 'Oropharyngeal cancer patients testing positive for human papillomavirus (HPV)'}, {'label': 'Group 2: HPV-positive Cancer', 'description': 'Oropharyngeal cancer patients who test positive for human papillomavirus (HPV)'}, {'label': 'Group 3: Healthy Controls', 'description': 'Patients with benign conditions'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131-0001', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Cancer Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Andrew Cowan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New Mexico Cancer Research Alliance', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}