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OpenTrials
Completed

NCT Number: NCT03302637

Oral Microbiome and Pancreatic Cancer

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.

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Key information

Age range

55 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

16S rRNA gene sequencing assay

Other

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.

Primary outcomes

  1. Presence or absence of bacterial taxa will be compared in oral and pancreatic samples.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
1992
Primary completion
2010
Study completion
2010
First posted
Oct 5, 2017
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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