Post-treatment Surveillance in HPV+ Oropharyngeal SCC

  • STATUS
    Recruiting
  • End date
    Nov 26, 2027
  • participants needed
    150
  • sponsor
    Dana-Farber Cancer Institute
Updated on 26 July 2021
Investigator
Eleni Rettig, MD
Primary Contact
Dana Farber Cancer Institute (4.5 mi away) Contact

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.

Details
Condition human papillomavirus vaccine, Oropharyngeal Squamous Cell Carcinoma, Human Papillomavirus Infection, HPV Infection, hpv vaccine, human papilloma virus vaccine, HPV
Treatment Screening
Clinical Study IdentifierNCT04965792
SponsorDana-Farber Cancer Institute
Last Modified on26 July 2021

Eligibility

Yes No Not Sure

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 prior to treatment

Exclusion Criteria

Distant metastatic disease (M1, AJCC 8th edition)
Undetectable ctHPV DNA result at baseline
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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