Clinical trial NCT04965792: Post-treatment Surveillance in HPV+ Oropharyngeal SCC
Official title: Circulating HPV DNA for Post-treatment Surveillance in HPV-positive Oropharyngeal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HPV
Oropharyngeal Squamous Cell Carcinoma
Keywords: HPV
Oropharyngeal Squamous Cell Carcinoma
HPV + Oropharyngeal Squamous Cell Carcinoma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with HPV-positive oropharynx cancer undergoing curative-intent treatment.

Brief summary: 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.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Recurrent disease Rate
timeFrame: Up to 5 years
Secondary outcomes:
measure: Recurrence Detection Predictive Properties
timeFrame: Time from first positive ctHPV DNA test to diagnosis of recurrence, assessed up to 5 years
measure: Time to diagnosis of recurrence
timeFrame: Time from first positive ctHPV DNA test to confirmed diagnosis of recurrence, assessed up to 5 years
measure: Progression-free survival (PFS)
timeFrame: Time from registration to the earlier of progression or death due to any cause, assessed up to 5 years
measure: Overall survival (OS)
timeFrame: Time from registration to death due to any cause, or censored at date last known alive, assessed up to 5 years
measure: Quality of Life (QOL)
timeFrame: Pre-study, at 3 and 6 months, then at every other visit for the duration of the study up to 5 years
measure: Cost Comparison
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Eleni M Rettig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rettig EM, Schoenfeld JD, Miller J, Sargent B, Carey E, Margalit DN, Sehgal K, Sethi RKV, Uppaluri R, Tishler RB, Goguen LA, Annino DJ, Sim ES, Jo VY, Wong KS, Guenette JP, Haddad RI, Hanna GJ. A Prospective Trial of Biomarker-Guided Surveillance for HPV-Positive Oropharynx Cancer Using Plasma Tumor Tissue-Modified Viral HPV DNA. Clin Cancer Res. 2025 May 1;31(9):1605-1614. doi: 10.1158/1078-0432.CCR-24-3053.