Neoplasms

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Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

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Neoplasms, Squamous Cell

Head and Neck Neoplasms

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

Screening

Eleni M Rettig, MD

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.

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.

Post-treatment Surveillance in HPV+ Oropharyngeal SCC

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

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.

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.

Estimate positive and negative predictive value, sensitivity and specificity of ctHPV DNA for subsequent diagnosis of recurrent HPV-OPC

The median (IQR) number of months between the first positive ctHPV DNA test to definitive diagnosis of recurrence will be calculated.

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).

Projected cost of ctHPV DNA-based compared with standard surveillance

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Post-treatment Surveillance in HPV+ Oropharyngeal SCC	NCT04965792	HPV Oropharyngeal S...	Screening	18 Years -	Dana-Farber Cancer Institute
Post-treatment Surveillance in HPV+ Oropharyngeal SCC	NCT04965792	HPV Oropharyngeal S...	Screening	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for hpv + oropharyngeal squamous cell carcinoma