The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer

NYU Langone Health

Status: Completed

Conditions: Oral Cancer

Treatments: Other: Classification of Oral Microbiome Using taxonomic approach; Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03304132

10-01834

Details and patient eligibility

About

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.

Full 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.

Enrollment: 560 patients

Sex: All

Ages: 40 to 92 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

560 participants in 2 patient groups

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),

Treatment:

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

Other: Classification of Oral Microbiome Using taxonomic approach

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),

Treatment:

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

Other: Classification of Oral Microbiome Using taxonomic approach