The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer

Completed

• Conditions: Oral Cancer
• Interventions: Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach; Other: Classification of Oral Microbiome Using taxonomic approach

• Registration Number: NCT03304132
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1992-12-01
• Primary Completion: 2010-12-01
• Study Completion: 2010-12-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-03
• Last Update Submitted: 2017-10-05
• Study First Posted: 2017-10-06
• Last Update Posted: 2017-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

• Diagnosis of Upper Aerodigestive Squamous Cell Cancer and registered in:
• The American Cancer Society Cancer Prevention Study II (CPS-II)
• The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Upper aerodigestive squamous cell cancers (UADSCC) cases	Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach	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),
Controls	Classification of Oral Microbiome Using taxonomic approach	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),
Upper aerodigestive squamous cell cancers (UADSCC) cases	Classification of Oral Microbiome Using taxonomic approach	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),
Controls	Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach	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),

Primary Outcome Measures

Name	Time	Method
16S rRNA gene survey approach for microbiome characterization	4 Years	Data alignment and clustering to determine microbiome species diversity

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States