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NCT Number: NCT04965792

Post-treatment Surveillance in HPV+ Oropharyngeal SCC

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

HPV Carcinoma Carcinoma, Squamous Cell Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Head and Neck Neoplasms Infections Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oropharyngeal Squamous Cell Carcinoma Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Squamous Cell Carcinoma of Head and Neck Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Screening

Other

Blood test

Primary outcomes

  1. Recurrent disease Rate

    Time frame: Up to 5 years

    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.

Secondary outcomes

  1. Recurrence Detection Predictive Properties

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

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

  2. Time to diagnosis of recurrence

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

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

  3. Progression-free survival (PFS)

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

    Calculated using Kaplan Meier method

  4. Overall survival (OS)

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

    Calculated using Kaplan Meier method

  5. Quality of Life (QOL)

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

    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).

  6. Cost Comparison

    Time frame: Up to 5 years

    Projected cost of ctHPV DNA-based compared with standard surveillance

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

Circulating HPV DNA for Post-treatment Surveillance in HPV-positive Oropharyngeal Squamous Cell Carcinoma

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jul 16, 2021
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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