Oral Microbiome and Pancreatic Cancer

Completed

• Conditions: Pancreatic Cancer
• Interventions: Other: 16S rRNA gene sequencing assay

• Registration Number: NCT03302637
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 1992-12-01
• Primary Completion: 2010-12-01
• Study Completion: 2010-12-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-02
• Last Update Submitted: 2017-10-04
• Study First Posted: 2017-10-05
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 732

Inclusion Criteria

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

Read More

Exclusion Criteria

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	16S rRNA gene sequencing assay	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.
Cases	16S rRNA gene sequencing assay	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.

Primary Outcome Measures

Name	Time	Method
Presence or absence of bacterial taxa will be compared in oral and pancreatic samples.	4 Years	For the taxa present at both sites, correlation between the abundance of taxa will be examined between the two sites. To adjust for confounders, multivariate linear regression will be used with abundance of oral taxa (exposure) and that of pancreas taxa (outcome).

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States