Purpose

In this research study the investigators are examining a blood test to detect HPV DNA in the blood that can possibly detect cancer recurrence earlier than with standard surveillance measures.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants must have histologically or cytologically confirmed incident or recurrent squamous cell carcinoma of the tonsil or base of tongue (oropharynx) - includes biopsy of any lymph node with clinical evidence of an oropharynx tumor (unknown primary carcinoma in an involved cervical neck lymph node is permitted if high-risk HPV testing is positive on the involved node) - HPV-associated tumor as defined by one or more : positive p16 immunohistochemistry (>70%) OR in situ hybridization OR PCR-based methods - Age 18 years or older - Will undergo oropharyngeal cancer treatment with curative intent - Ability to understand and the willingness to sign a written informed consent document. - Baseline positive or detectable ctHPV DNA result prior to treatment

Exclusion Criteria

  • Distant metastatic disease (M1, AJCC 8th edition) - Undetectable ctHPV DNA result at baseline

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC) Patients Newly diagnosed HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC) patients will undergo blood testing for circulating tumor HPV DNA.
  • Other: Screening
    Blood test

Recruiting Locations

Dana Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Robert Haddad, MD
617-632-3779
rhaddad@partners.org

More Details

Status
Recruiting
Sponsor
Dana-Farber Cancer Institute

Study Contact

Eleni M Rettig, MD
617-632-3643
emrettig@bwh.harvard.edu

Detailed Description

This research study involves blood tests to detect HPV DNA at regular time points after treatment for HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC). Participants may undergo scans based on the results of the blood tests. Study participants will also be asked to complete quality of life questionnaires periodically. Participation in this study may last for up to 5 years. It is expected that about 150 people will take part in this research study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.