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The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer

NCT ID: NCT03304132

Last Updated: 2017-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

560 participants

Study Classification

OBSERVATIONAL

Study Start Date

1992-12-01

Study Completion Date

2010-12-01

Brief Summary

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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

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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.

Conditions

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Oral Cancer

Keywords

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Oral Microbiome reflux disorders esophageal microbiome Alcohol Use Tobacco Use

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Upper aerodigestive squamous cell cancers (UADSCC) cases

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),

Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach

Intervention Type OTHER

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.

Classification of Oral Microbiome Using taxonomic approach

Intervention Type OTHER

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.

Controls

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),

Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach

Intervention Type OTHER

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.

Classification of Oral Microbiome Using taxonomic approach

Intervention Type OTHER

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.

Interventions

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Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach

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.

Intervention Type OTHER

Classification of Oral Microbiome Using taxonomic approach

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

92 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiyoung Ahn, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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10-01834

Identifier Type: -

Identifier Source: org_study_id