Oropharynx (OPX) Salivary Biomarker Study

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Healthy non-cancerous participants

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Saliva; saliva from "normal healthy" adults.	Other: no intervention; saliva collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oncologic strains in HPV DNA salivary samples	Number of patients to have oncologic strains of HPV DNA in salivary samples	2 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Kathryn Van Abel, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21-006529

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No