Clinical trial · Observational
The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach | Other | — | UNRESOLVED |
| Classification of Oral Microbiome Using taxonomic approach | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Upper aerodigestive squamous cell cancers (UADSCC) cases
- description
- 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),
- interventionNames
- Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach
- Other: Classification of Oral Microbiome Using taxonomic approach
- label
- Controls
- description
- 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),
- interventionNames
- Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach
- Other: Classification of Oral Microbiome Using taxonomic approach
Primary outcomes (1)
- measure
- 16S rRNA gene survey approach for microbiome characterization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 92 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available