A Study to Validate HPV DNA Genotyping and Prognostic Genomic Biomarkers for Diagnosis

Overview

About this study

The primary purpose of this study is to assess novel tumor genomic biomarkers (TRAF3 and CYLD gene defects and HPV integration) of recurrence risk in patients with Human papillomavirus+oropharyngeal squamous cell carcinoma (HPV+OPSCC) undergoing curative-intent therapy.

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:

≥ 18 years of age.
T0-T2 N2a-N3 M0 or T3-T4 N0-N3 M0 (AJCC 7th edition).
Biopsy proven squamous cell carcinoma of the oropharynx or unknown primary.
No prior therapy.
No evidence of distant metastatic disease.
p16 positive = diffuse ≥ 70% tumor cell expression, with at least moderate (2/3+) staining intensity.
Planned for receipt of definitive cancer treatment.
ECOG Performance Status 0-1.
Patients must be deemed able to comply with the treatment plan and follow-up schedule.
Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

Prior history of radiation therapy to the head and neck.
Prior history of head and neck cancer.
Inadequate pre-treatment tissue sample for tumor genomic analyses.

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 Daniel Ma, M.D.	Closed for enrollment	Contact information: Kayla Tottingham (507) 293-1275 Tottingham.Kayla@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Daniel Ma, M.D.

Closed for enrollment

Contact information:

Kayla Tottingham

(507) 293-1275

Tottingham.Kayla@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials