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OPX Saliva Biomarker Study

Overview

About this study

  1. Salivary tumor DNA (stDNA) and the HPV self-test for oncogenic HPV (self-test) will be detectable in patients with human papillomavirus associated oropharyngeal squamous cell carcinoma (HPV(+)OPSCC) and not in HPV(-)OPSCC, oral cavity cancer or normal controls.
     
  2. There will be a difference in the microbiome, virome, and metabolomics in normal control patients compared to patients with oropharyngeal cancer or oral cavity cancer.
     
  3. There will be a difference in patient reported risk factors between patients with malignancy and normal controls.
     
  4. There will be dynamic changes in the microbiome and metabolomics which correspond with patient reported outcomes in patients with oropharyngeal cancer or oral cavity cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kathryn Van Abel, M.D.

Closed for enrollment

Contact information:

Amy Tuchscherer C.C.R.C.

(507) 538-6582

Tuchscherer.Amy@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20542637

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