Oropharynx (OPX) Salivary Biomarker Study

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05093400
• Other study ID #: 21-006529
• Status: Completed
• Start date: September 17, 2021
• Est. completion date: May 5, 2023

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 5, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• no intervention
saliva collection

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oncologic strains in HPV DNA salivary samples	Number of patients to have oncologic strains of HPV DNA in salivary samples	2 years

External Links

•   Mayo Clinic Clinical Trials