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OpenTrials
Completed

NCT Number: NCT05093400

Oropharynx (OPX) Salivary Biomarker Study

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.

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Key information

Conditions

Healthy

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

saliva collection

Primary outcomes

  1. Oncologic strains in HPV DNA salivary samples

    Time frame: 2 years

    Number of patients to have oncologic strains of HPV DNA in salivary samples

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2021
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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