Oropharynx (OPX) Salivary Biomarker Study

Completed

• Conditions: Healthy
• Interventions: Other: no intervention

• Registration Number: NCT05093400
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-17
• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-10-26
• Primary Completion: 2023-05-02
• Study Completion: 2023-05-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-05
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Saliva	no intervention	saliva from "normal healthy" adults.

Primary Outcome Measures

Name	Time	Method
Oncologic strains in HPV DNA salivary samples	2 years	Number of patients to have oncologic strains of HPV DNA in salivary samples

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States