Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-03-01 @ 10:50 PM
Study NCT ID:
NCT03304132
Status:
COMPLETED
Last Update Posted:
2017-10-09
First Post:
2017-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D064424', 'term': 'Tobacco Use'}], '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'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '140 UADSCC cases and 420 controls using Roche 454 16S rRNA gene sequencing.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 560}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1992-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2010-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-05', 'studyFirstSubmitDate': '2017-10-03', 'studyFirstSubmitQcDate': '2017-10-03', 'lastUpdatePostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '16S rRNA gene survey approach for microbiome characterization', 'timeFrame': '4 Years', 'description': 'Data alignment and clustering to determine microbiome species diversity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral Microbiome', 'reflux disorders', 'esophageal microbiome', 'Alcohol Use', 'Tobacco Use'], 'conditions': ['Oral Cancer']}, 'descriptionModule': {'briefSummary': 'The human oral cavity is a diverse habitat that contains approximately 700 prokaryotic species. The oral microbiome is comprised of 44% named species, 12% isolates representing unnamed species, and 44% phylotypes known only from 16S rRNA based cloning studies (http://www.homd.org/). Species from 11 phyla have been identified: Firmicutes, Bacteroidetes, Proteobacteria, Actinobacteria, Spirochaetes, Fusobacteria, TM7, Synergistetes, Chlamydiae, Chloroflexi and SR1 (http://www.homd.org/). Because these observations have been mainly based on data generated from traditional Sanger sequencing, the diversity of oral microbiome is highly likely underestimated. Application of high throughput sequencing to the oral microbiome similar to the scale of the microbiome studies of other body sites (GI tract, skin, and vagina) under the Human Microbiome Project is necessary to obtain data essential for understanding the diversity and community structure of the oral microbiome in health and disease.', 'detailedDescription': 'The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial and The American Cancer Society Cancer Prevention Study II (CPS-II) investigators have identified 140 UADSCC cases that have been frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO), gender, ethnic background, and age, within 10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '92 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The American Cancer Society Cancer (ACS) Prevention Study II Nutrition Cohort (CPS-II) was established in 1992; the cohort includes over 86,000 men and 97,000 women from 21 U.S. states who completed a mailed questionnaire in 1992. In total, 72 UADSCC were eligible for study, with completed informed consent and prediagnostic oral wash collection.\n\nThe Prostate, Lung, Colon and Ovarian (PLCO) Cancer Screening Trial is a randomized controlled trial of approximately 155,000 men and women. Participants are randomized to either a screening or control arm. n total, 68 UADSCC were eligible for study, including completed informed consent and prediagnostic oral wash collection.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Upper Aerodigestive Squamous Cell Cancer and registered in:\n* The American Cancer Society Cancer Prevention Study II (CPS-II)\n* The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.'}, 'identificationModule': {'nctId': 'NCT03304132', 'briefTitle': 'The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer', 'orgStudyIdInfo': {'id': '10-01834'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Upper aerodigestive squamous cell cancers (UADSCC) cases', 'description': 'From PLCO and ACS CPS II, identified 140 UADSCC cases. These cases are frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO),', 'interventionNames': ['Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach', 'Other: Classification of Oral Microbiome Using taxonomic approach']}, {'label': 'Controls', 'description': 'From PLCO and ACS CPS II, we have identified 140 UADSCC cases. These cases are frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO),', 'interventionNames': ['Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach', 'Other: Classification of Oral Microbiome Using taxonomic approach']}], 'interventions': [{'name': 'Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach', 'type': 'OTHER', 'description': 'The sequence-based approach is selected because it classifies samples by considering the entire difference (genetic distance) in 16S rRNA gene sequences among samples analyzed, unbiased by artificial details such as taxonomies, sequence length, or even quality scores.', 'armGroupLabels': ['Controls', 'Upper aerodigestive squamous cell cancers (UADSCC) cases']}, {'name': 'Classification of Oral Microbiome Using taxonomic approach', 'type': 'OTHER', 'description': 'The taxonomic approach is a complement to the sequence-based approach in that it will further identify specific taxonomic groups or species that can explain the difference found by overall analyses.', 'armGroupLabels': ['Controls', 'Upper aerodigestive squamous cell cancers (UADSCC) cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jiyoung Ahn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}