NCT06915038 ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx
| NCT ID | NCT06915038 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Squamous Cell Carcinoma of Oropharynx |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-06-11 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-06-11 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Pre-Surgery * 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. Post-Surgery • Subjects with unknown primaries included if primary is definitively identified and resectable with negative margins or if the palatine and lingual tonsils are thoroughly resected and pathologically proven to be negative for a primary. Exclusion Criteria: * 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.
Contact & Investigator
Michael Sim, MD
PRINCIPAL INVESTIGATOR
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06915038 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Squamous Cell Carcinoma of Oropharynx. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06915038 currently recruiting?
Yes, NCT06915038 is actively recruiting participants. Contact the research team at ayekinn@iu.edu for enrollment information.
Where is the NCT06915038 trial being conducted?
This trial is being conducted at Carmel, United States, Indianapolis, United States.
Who is sponsoring the NCT06915038 clinical trial?
NCT06915038 is sponsored by Indiana University. The principal investigator is Michael Sim, MD at Indiana University Melvin and Bren Simon Comprehensive Cancer Center. The trial plans to enroll 120 participants.