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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

Tracking Information
First Submitted Date October 2, 2017
First Posted Date October 5, 2017
Last Update Posted Date October 6, 2017
Actual Study Start Date December 1, 1992
Actual Primary Completion Date December 1, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 2, 2017)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03302637 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oral Microbiome and Pancreatic Cancer
Official Title Oral Microbiome and Pancreatic Cancer: a Prospective Case-Control Study
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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
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.
Condition Pancreatic Cancer
Intervention 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.
Study Groups/Cohorts
  • 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.
    Intervention: Other: 16S rRNA gene sequencing assay
  • 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.
    Intervention: Other: 16S rRNA gene sequencing assay
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 2, 2017)
732
Original Actual Enrollment Same as current
Actual Study Completion Date December 1, 2010
Actual Primary Completion Date December 1, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03302637
Other Study ID Numbers 12-00721
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party NYU Langone Health
Study Sponsor NYU Langone Health
Collaborators Not Provided
Investigators
Principal Investigator: Jiyoung Ahn, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date October 2017