NCT03304132

The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 560 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 40 Years – 92 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oral Cancer

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 1992-12-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2017-10-06
• Last updated: 2017-10-09

Locations

1 site across 1 country: United States