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Oral Microbiome and Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03302637
Recruitment Status : Completed
First Posted : October 5, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Pancreatic Cancer Other: 16S rRNA gene sequencing assay

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.

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Study Type : Observational
Actual Enrollment : 732 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Oral Microbiome and Pancreatic Cancer: a Prospective Case-Control Study
Actual Study Start Date : December 1, 1992
Actual Primary Completion Date : December 1, 2010
Actual Study Completion Date : December 1, 2010

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cases
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.
Other: 16S 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.

Control
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.
Other: 16S 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.




Primary Outcome Measures :
  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).


Biospecimen Retention:   Samples With DNA
Using DNA extracted from oral samples from these cohorts, 16S rRNA genes were amplified and sequenced, followed by assignment of each sequence to a microbial taxa


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
361 incident adenocarcinoma of pancreas and 371 matched controls from two prospective cohort studies, the American Cancer Society Cancer Prevention Study II and the National Cancer Institute Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302637


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Jiyoung Ahn, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03302637     History of Changes
Other Study ID Numbers: 12-00721
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases