Post-treatment Surveillance in HPV+ Oropharyngeal SCC

Dana-Farber Cancer Institute

Status

Active, not recruiting

Conditions

HPV

Oropharyngeal Squamous Cell Carcinoma

Treatments

Other: Screening

Study type

Observational

Funder types

Other

Identifiers

NCT04965792

20-340

Details and patient eligibility

About

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.

Full 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 3 years. It is expected that about 150 people will take part in this research study.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 in plasma OR detectable corresponding HPV DNA in tumor tissue prior to treatment

Exclusion criteria