An observational study in Oral Cancer, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 40 Years to 92 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-09.
Sponsored by NYU Langone Health · Observational
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.
446 studies on the registry are indexed under Mouth Neoplasms; 130 are open to participants now.
This study's enrollment of 560 is above the median of 100 across 113 observational studies indexed under Mouth Neoplasms.
Browse Mouth Neoplasms studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
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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.
Inclusion Criteria:
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
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
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.
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.
16S rRNA gene survey approach for microbiome characterization
Data alignment and clustering to determine microbiome species diversity
Time frame: 4 Years
Plan to share: No
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Ran from Dec 1992 to primary completion in Dec 2010, 216 months.
Of 44 non-industry observational studies under Mouth Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 216. This study's 216 months is above that.
Counting every sponsor, half of 48 studies reached it within 47 months; a quarter within 23 and three quarters within 216.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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