The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer

Oral Cancer Clinical Trial

Official title:

The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304132
• Other study ID #: 10-01834
• Status: Completed
• Phase: N/A
• First received: October 3, 2017
• Last updated: October 5, 2017
• Start date: December 1, 1992
• Est. completion date: December 1, 2010

Study information

• Verified date: October 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial and The American Cancer Society Cancer Prevention Study II (CPS-II) investigators have identified 140 UADSCC cases that have been frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO), gender, ethnic background, and age, within 10 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: December 1, 2010
• Est. primary completion date: December 1, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 92 Years

Eligibility

Inclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Mouth Neoplasms
• Neoplasms, Squamous Cell
• Oral Cancer

Intervention

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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	16S rRNA gene survey approach for microbiome characterization	Data alignment and clustering to determine microbiome species diversity	4 Years