Oropharynx (OPX) Salivary Biomarker Study

Mayo Clinic

Status: Completed

Conditions: Healthy

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05093400

21-006529

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Normal Saliva

Description:

saliva from "normal healthy" adults.

Treatment:

Other: no intervention