RECRUITING

ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx

Conditions

Squamous Cell Carcinoma of Oropharynx HPV Positive Cancer Throat Cancer Tonsil Cancer NavDX HPVctDNA HPV transoral surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a prospective phase II trial, designed to assess the efficacy and feasibility of adjuvant treatment deintensification guided by ctHPVDNA levels for patients with HPV+OPSCC who undergo transoral surgery and neck dissection.

Official Title

Circulating Tumor HPV DNA Driven Adjuvant Treatment Deintensification After Transoral Surgery for HPV-Positive Squamous Cell Carcinoma of the Oropharynx

Quick Facts

Study Start:2025-06-11

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06915038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subjects ≥ 18 years old at the time of informed consent. * Ability to provide written informed consent and HIPAA authorization. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls of oropharynx). * Histopathologically confirmed squamous cell carcinoma. * Detectable ctHPVDNA from blood samples collected prior to treatment. * Resectable and accessible tumor with high probability of achieving negative margins. * Smokers and non-smokers included. * Tumor stage (AJCC 8th edition): T1 or T2, and select T3 tumors that are mobile and do not invade the larynx. * Nodal stage (AJCC 8th edition): N0, N1 or N2. * Mobile neck nodes on physical exam if N positive. * HPV+ tumor, as determined by p16, in-situ hybridization, real-time polymerase chain reaction, or ctHPVDNA.	* Serious medical condition preventing general anesthesia for surgery. * History of previous head and neck radiation or previous head and neck cancer within 3 years. * Distant metastatic disease present. * Subjects with synchronous HPV+ oropharynx primaries * Prior invasive malignant disease within 3 years, with the exception of non-melanoma skin cancer and thyroid cancer, unless patient is deemed cured or disease free, in which case patient may be included in the study. * Lactating or pregnant women. Women of childbearing potential must have a negative pregnancy test on the day of surgery. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria: 1. Has undergone a hysterectomy or bilateral oophorectomy; or 2. Has been naturally amenorrheic for at least 12 consecutive months.

Inclusion Criteria

Exclusion Criteria

* Subjects ≥ 18 years old at the time of informed consent.
* Ability to provide written informed consent and HIPAA authorization.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls of oropharynx).
* Histopathologically confirmed squamous cell carcinoma.
* Detectable ctHPVDNA from blood samples collected prior to treatment.
* Resectable and accessible tumor with high probability of achieving negative margins.
* Smokers and non-smokers included.
* Tumor stage (AJCC 8th edition): T1 or T2, and select T3 tumors that are mobile and do not invade the larynx.
* Nodal stage (AJCC 8th edition): N0, N1 or N2.
* Mobile neck nodes on physical exam if N positive.
* HPV+ tumor, as determined by p16, in-situ hybridization, real-time polymerase chain reaction, or ctHPVDNA.

* Serious medical condition preventing general anesthesia for surgery.
* History of previous head and neck radiation or previous head and neck cancer within 3 years.
* Distant metastatic disease present.
* Subjects with synchronous HPV+ oropharynx primaries
* Prior invasive malignant disease within 3 years, with the exception of non-melanoma skin cancer and thyroid cancer, unless patient is deemed cured or disease free, in which case patient may be included in the study.
* Lactating or pregnant women. Women of childbearing potential must have a negative pregnancy test on the day of surgery. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:
1. Has undergone a hysterectomy or bilateral oophorectomy; or
2. Has been naturally amenorrheic for at least 12 consecutive months.

Contacts and Locations

Study Contact

Azeezat Yekinni

CONTACT

317-529-6883

ayekinn@iu.edu

Principal Investigator

Michael Sim, MD

PRINCIPAL_INVESTIGATOR

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Study Locations (Sites)

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032

United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Indiana University

Michael Sim, MD, PRINCIPAL_INVESTIGATOR, Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-11

Study Completion Date2028-12

Study Record Updates

Study Start Date2025-06-11

Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

NavDX
HPVctDNA
HPV
transoral surgery

Additional Relevant MeSH Terms

Squamous Cell Carcinoma of Oropharynx
HPV Positive Cancer
Throat Cancer
Tonsil Cancer