Post-treatment Surveillance in HPV+ Oropharyngeal SCC

• ClinicalTrials.gov Identifier: NCT04965792
• Recruitment Status: Active, not recruiting
• First Posted: July 16, 2021
• Last Update Posted: July 13, 2023
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Eleni Marie Rettig, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: April 19, 2021
• First Posted Date: July 16, 2021
• Last Update Posted Date: July 13, 2023
• Actual Study Start Date: November 19, 2020
• Estimated Primary Completion Date: November 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 14, 2021)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 14, 2021)

• 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
• 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.
• 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
• 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
• 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).
• Cost Comparison [ Time Frame: Up to 5 years ]
  Projected cost of ctHPV DNA-based compared with standard surveillance

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Post-treatment Surveillance in HPV+ Oropharyngeal SCC
• Official Title: Circulating HPV DNA for Post-treatment Surveillance in HPV-positive Oropharyngeal Squamous Cell Carcinoma
• 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 5 years. It is expected that about 150 people will take part in this research study.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood

• Sampling Method: Probability Sample
• Study Population: Individuals with HPV-positive oropharynx cancer undergoing curative-intent treatment.

Condition

• HPV
• Oropharyngeal Squamous Cell Carcinoma

Intervention

Other: Screening

Blood test

Study Groups/Cohorts

HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC) Patients

Newly diagnosed HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC) patients will undergo blood testing for circulating tumor HPV DNA.

Intervention: Other: Screening

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 14, 2021): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2027
• Estimated Primary Completion Date: November 2026 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04965792
• Other Study ID Numbers: 20-340
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu Contact the Partners Innovations team at http://www.partners.org/innovation

• Current Responsible Party: Eleni Marie Rettig, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Eleni Marie Rettig, Dana-Farber Cancer Institute, Principal Investigator
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Eleni M Rettig, MD; Brigham and Women's Hospital

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: July 2023