The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03304132

Enrollment

560

Registered

2017-10-06

Start date

1992-12-01

Completion date

2010-12-01

Last updated

2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cancer

Keywords

Oral Microbiome, reflux disorders, esophageal microbiome, Alcohol Use, Tobacco Use

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.

Interventions

OTHERClassification 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.

OTHERClassification 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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 92 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026