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Oropharynx (OPX) Salivary Biomarker Study

Oropharynx (OPX) Salivary Biomarker Study: Microbiome, Virome, and Metabolomics

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05093400
Enrollment
100
Registered
2021-10-26
Start date
2021-09-17
Completion date
2023-05-05
Last updated
2023-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The goal of this study is to analyze certain biomarkers to look at the relationship between HPV in the saliva, stage at presentation, and a potential self-test compared to saliva of non-cancerous participants.

Interventions

OTHERno intervention

saliva collection

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* Oropharynx or Oral Cavity Squamous Cell Carcinoma Patients: collected under the OPX Biomarker Protocol (IRB: 19-006036). Normal Controls: * Age ≥ 18 years; * Able to provide informed written consent documenting permission to give saliva sample for research testing.; * Ability to complete questionnaire(s) by themselves or with assistance.

Exclusion criteria

* Oropharynx or Oral Cavity Squamous Cell Carcinoma Patients: collected under the OPX Biomarker Protocol (IRB: 19-006036). Normal Controls: * Any personal history of head or neck cancer including head or neck skin cancer. * Other active malignancy ≤ 5 years prior to registration. * EXCEPTIONS: Non-melanotic skin cancer, non-metastatic prostate cancer. * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer. * Dry mouth (xerostomia) caused by any chronic (\>30 days) condition (known or unknown) or medication. * Recent (within 30 days) or active upper aerodigestive tract or anogenital infections.

Design outcomes

Primary

MeasureTime frameDescription
Oncologic strains in HPV DNA salivary samples2 yearsNumber of patients to have oncologic strains of HPV DNA in salivary samples

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026