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Trial record 15 of 2060 for:    Oral Cancer | NIH

The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer

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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

October 3, 2017
October 6, 2017
October 9, 2017
December 1, 1992
December 1, 2010   (Final data collection date for primary outcome measure)
16S rRNA gene survey approach for microbiome characterization [ Time Frame: 4 Years ]
Data alignment and clustering to determine microbiome species diversity
Same as current
Complete list of historical versions of study NCT03304132 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer
The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer
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.
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.
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
140 UADSCC cases and 420 controls using Roche 454 16S rRNA gene sequencing.
Non-Probability Sample

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.

Oral Cancer
  • 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.
  • 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),
    Interventions:
    • 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),
    Interventions:
    • Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach
    • Other: Classification of Oral Microbiome Using taxonomic approach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
560
Same as current
December 1, 2010
December 1, 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years to 92 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03304132
10-01834
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
New York University School of Medicine
New York University School of Medicine
National Institutes of Health (NIH)
Principal Investigator: Jiyoung Ahn, MD New York University School of Medicine
New York University School of Medicine
October 2017