Post-treatment Surveillance in HPV+ Oropharyngeal SCC

HPV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04965792
• Other study ID #: 20-340
• Status: Active, not recruiting
• Start date: November 19, 2020
• Est. completion date: November 2027

Study information

• Verified date: July 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: November 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• HPV
• Oropharyngeal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Other:
• Screening
Blood test

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 years
Secondary	Recurrence Detection Predictive Properties	Estimate positive and negative predictive value, sensitivity and specificity of ctHPV DNA for subsequent diagnosis of recurrent HPV-OPC	Time from first positive ctHPV DNA test to diagnosis of recurrence, assessed up to 5 years
Secondary	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 from first positive ctHPV DNA test to confirmed diagnosis of recurrence, assessed up to 5 years
Secondary	Progression-free survival (PFS)	Calculated using Kaplan Meier method	Time from registration to the earlier of progression or death due to any cause, assessed up to 5 years
Secondary	Overall survival (OS)	Calculated using Kaplan Meier method	Time from registration to death due to any cause, or censored at date last known alive, assessed up to 5 years
Secondary	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).	Pre-study, at 3 and 6 months, then at every other visit for the duration of the study up to 5 years
Secondary	Cost Comparison	Projected cost of ctHPV DNA-based compared with standard surveillance	Up to 5 years