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Oral Microbiome and Pancreatic Cancer

Oral Microbiome and Pancreatic Cancer: a Prospective Case-Control Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03302637
Enrollment
732
Registered
2017-10-05
Start date
1992-12-01
Completion date
2010-12-01
Last updated
2017-10-06

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

Conditions

Pancreatic Cancer

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.

Interventions

OTHER16S rRNA gene sequencing assay

extraction of genomic DNA from oral samples using the Mobio DNA Isolation Kit. 16S rRNA amplicons covering variable regions V3 to V4 will be generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3')66 incorporating adapters and a sample barcode sequence at PI's lab. Amplicons will be sequenced with the Roche 454 FLX Titanium sequencing system at the NYU genome technology center, following the manufacturer's specifications.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to 74 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Presence or absence of bacterial taxa will be compared in oral and pancreatic samples.4 YearsFor 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).

Countries

United States

Outcome results

None listed

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