ClinicalTrials.gov
ClinicalTrials.gov Menu

The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03304132
Recruitment Status : Completed
First Posted : October 6, 2017
Last Update Posted : October 9, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment
Oral Cancer Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach Other: Classification of Oral Microbiome Using taxonomic approach

Detailed 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.

Study Type : Observational
Actual Enrollment : 560 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer
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
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
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.

Other: 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.

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
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.

Other: 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.




Primary Outcome Measures :
  1. 16S rRNA gene survey approach for microbiome characterization [ Time Frame: 4 Years ]
    Data alignment and clustering to determine microbiome species diversity


Biospecimen Retention:   Samples With DNA
140 UADSCC cases and 420 controls using Roche 454 16S rRNA gene sequencing.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 92 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.

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): NCT03304132


Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Institutes of Health (NIH)
Investigators
Principal Investigator: Jiyoung Ahn, MD New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03304132     History of Changes
Other Study ID Numbers: 10-01834
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
Oral Microbiome
reflux disorders
esophageal microbiome
Alcohol Use
Tobacco Use

Additional relevant MeSH terms:
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Mouth Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases