Oral Microbiome and Pancreatic Cancer

NYU Langone Health

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Other: 16S rRNA gene sequencing assay

Study type: Observational

Funder types: Other

Identifiers

NCT03302637

12-00721

Details and patient eligibility

About

This is a prospective population based study to examine the relationship of oral and pancreatic microbiome, and their functions, to pancreatic cancer risk.

The identification of specific oral bacteria and their functional relationship to pancreatic cancer will advance scientific knowledge on the etiology of pancreatic cancer. This could provide a new microbially-based research paradigm, possibly leading to new drug targets for this disease. Second, the oral bacteria may serve as a readily accessible, non-invasive biomarker for subsequent pancreatic cancer risk, which help to identify people at high risk of this disease. Finally, the identified oral bacteria may lead to microbial prophylactic preventions, with antibiotic therapy aimed at eradicating the specific species associated with increased cancer risk or, alternatively, combined with probiotics to introduce species that are associated with a decreased cancer risk. Thus, the study outcomes will lead to actionable means for pancreatic cancer prevention.

Full description

A history of periodontal disease and the presence of circulating antibodies to selected oral pathogens have been associated with increased risk of pancreatic cancer; however, direct relationships of oral microbes with pancreatic cancer have not been evaluated in prospective studies. Investigators examine the relationship of oral microbiota with subsequent risk of pancreatic cancer in a large nested case-control study.

Enrollment: 732 patients

Sex: All

Ages: 55 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• DNA extracted from oral wash samples from NIH-PLCO and ACS-CPS cohorts

Exclusion criteria

Trial design

732 participants in 2 patient groups

Cases

Description:

subjects with histology-confirmed incident pancreatic cancer, with no prior history of cancer (except non-melanoma skin cancer), a valid consent, and pre-diagnostic oral wash samples.

Treatment:

Other: 16S rRNA gene sequencing assay

Control

Description:

selected by incidence density sampling63 among cohort members who had no cancer prior to selection, provided a valid consent and an oral wash. Controls were frequency matched to cases by cohort, age at cohort entry (5 year), sex, race, and calendar year of cohort entry.

Treatment:

Other: 16S rRNA gene sequencing assay