Post-treatment Surveillance in HPV+ Oropharyngeal SCC

N/AActive Not RecruitingNCT04965792

Dana-Farber Cancer Institute150 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

HPV Oropharyngeal Squamous Cell Carcinoma

Interventions

ScreeningOTHER

Blood test

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: * Distant metastatic disease (M1, AJCC 8th edition)

Locations (1)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Recurrent disease Rate

The proportion of patients with recurrence first detected by ctHPV DNA will be calculated as a percentage and 95% confidence intervals (CI) established using binomial exact calculation.

Time frame: Up to 5 years

Secondary Outcomes

Recurrence Detection Predictive Properties

Estimate positive and negative predictive value, sensitivity and specificity of ctHPV DNA for subsequent diagnosis of recurrent HPV-OPC

Time frame: Time from first positive ctHPV DNA test to diagnosis of recurrence, assessed up to 5 years

Time to diagnosis of recurrence

The median (IQR) number of months between the first positive ctHPV DNA test to definitive diagnosis of recurrence will be calculated.

Time frame: Time from first positive ctHPV DNA test to confirmed diagnosis of recurrence, assessed up to 5 years

Progression-free survival (PFS)

Calculated using Kaplan Meier method

Time frame: Time from registration to the earlier of progression or death due to any cause, assessed up to 5 years

Overall survival (OS)

Calculated using Kaplan Meier method

Time frame: Time from registration to death due to any cause, or censored at date last known alive, assessed up to 5 years

Quality of Life (QOL)

QOL will be evaluated using the by Fear of Recurrence Questionnaire-Short Form (score range 6-40; lower score is lower fear of recurrence) and EQ-5D-5L questionnaire (5 questions with score range 1-5 where higher score is worse; and one question with score range 0-100 where higher is better).

Time frame: Pre-study, at 3 and 6 months, then at every other visit for the duration of the study up to 5 years

Data from ClinicalTrials.gov

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