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Post-treatment Surveillance in HPV+ Oropharyngeal SCC

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

Study Description
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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.

Condition or disease Intervention/treatment
HPV Oropharyngeal Squamous Cell Carcinoma Other: Screening

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 Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating HPV DNA for Post-treatment Surveillance in HPV-positive Oropharyngeal Squamous Cell Carcinoma
Actual Study Start Date : November 19, 2020
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : November 2027
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: Screening
Blood test


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals with HPV-positive oropharynx cancer undergoing curative-intent treatment.
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04965792


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Eleni M Rettig, MD Brigham and Women's Hospital
More Information
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Responsible Party: Eleni Marie Rettig, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04965792    
Other Study ID Numbers: 20-340
First Posted: July 16, 2021    Key Record Dates
Last Update Posted: July 13, 2023
Last Verified: July 2023
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eleni Marie Rettig, MD, Dana-Farber Cancer Institute:
HPV
Oropharyngeal Squamous Cell Carcinoma
HPV + Oropharyngeal Squamous Cell Carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site