The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer

NCT03304132 | Completed

• 1 other identifier: 10-01834
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

The human oral cavity is a diverse habitat that contains approximately 700 prokaryotic species. The oral microbiome is comprised of 44% named species, 12% isolates representing unnamed species, and 44% phylotypes known only from 16S rRNA based cloning studies (http://www.homd.org/). Species from 11 phyla have been identified: Firmicutes, Bacteroidetes, Proteobacteria, Actinobacteria, Spirochaetes, Fusobacteria, TM7, Synergistetes, Chlamydiae, Chloroflexi and SR1 (http://www.homd.org/). Because these observations have been mainly based on data generated from traditional Sanger sequencing, the diversity of oral microbiome is highly likely underestimated. Application of high throughput sequencing to the oral microbiome similar to the scale of the microbiome studies of other body sites (GI tract, skin, and vagina) under the Human Microbiome Project is necessary to obtain data essential for understanding the diversity and community structure of the oral microbiome in health and disease.

Conditions

Oral Cancer

Keywords

Oral Microbiome; reflux disorders; esophageal microbiome; Alcohol Use; Tobacco Use

Outcome Measures

Primary Outcomes (1)

• 16S rRNA gene survey approach for microbiome characterization

  Data alignment and clustering to determine microbiome species diversity

  4 Years

Study Arms (2)

Upper aerodigestive squamous cell cancers (UADSCC) cases

From PLCO and ACS CPS II, identified 140 UADSCC cases. These cases are frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO),

Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach; Other: Classification of Oral Microbiome Using taxonomic approach

Controls

From PLCO and ACS CPS II, we have identified 140 UADSCC cases. These cases are frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO),

Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach; Other: Classification of Oral Microbiome Using taxonomic approach

Interventions

Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach OTHER

The sequence-based approach is selected because it classifies samples by considering the entire difference (genetic distance) in 16S rRNA gene sequences among samples analyzed, unbiased by artificial details such as taxonomies, sequence length, or even quality scores.

Controls; Upper aerodigestive squamous cell cancers (UADSCC) cases

Classification of Oral Microbiome Using taxonomic approach OTHER

The taxonomic approach is a complement to the sequence-based approach in that it will further identify specific taxonomic groups or species that can explain the difference found by overall analyses.

Controls; Upper aerodigestive squamous cell cancers (UADSCC) cases

Eligibility Criteria

• Age: 40 Years - 92 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The American Cancer Society Cancer (ACS) Prevention Study II Nutrition Cohort (CPS-II) was established in 1992; the cohort includes over 86,000 men and 97,000 women from 21 U.S. states who completed a mailed questionnaire in 1992. In total, 72 UADSCC were eligible for study, with completed informed consent and prediagnostic oral wash collection. The Prostate, Lung, Colon and Ovarian (PLCO) Cancer Screening Trial is a randomized controlled trial of approximately 155,000 men and women. Participants are randomized to either a screening or control arm. n total, 68 UADSCC were eligible for study, including completed informed consent and prediagnostic oral wash collection.

You may qualify if:

• Diagnosis of Upper Aerodigestive Squamous Cell Cancer and registered in:
• The American Cancer Society Cancer Prevention Study II (CPS-II)
• The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

140 UADSCC cases and 420 controls using Roche 454 16S rRNA gene sequencing.

MeSH Terms

Conditions

Mouth Neoplasms; Alcohol Drinking; Tobacco Use

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Drinking Behavior; Behavior

Study Officials

• Jiyoung Ahn, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 6, 2017
• Study Start: December 1, 1992
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 9, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)