RecruitingNCT04099290

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

50 participants

Start Date

Jan 14, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

Circulating tumor DNA (ctDNA) is a blood-based test that measures dying or dead cancer cells that are already circulating in the blood. In this study, the investigators will enroll patients who are planning to receive surgery to remove their head and neck cancer. The investigators are interested to learn how ctDNA levels change with surgery and over the course of time. The investigators also want to determine if there are certain features of the tumor or the patient themselves that might cause ctDNA to be higher than other patients. Also, the investigators want to explore if the detection of ctDNA following surgery is related to cancer recurrence.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is measuring circulating tumor DNA (ctDNA) — tiny fragments of cancer DNA found in the blood — in patients with head and neck squamous cell carcinoma who are undergoing surgery. The goal is to understand whether blood-based tests can detect remaining cancer after surgery and predict who needs additional treatment. **You may be eligible if...** - You are 18 or older - You have a newly diagnosed squamous cell carcinoma of the mouth, throat, or voice box, confirmed by biopsy - You are planning to undergo surgery to remove the tumor at UNC-CH hospital with the goal of cure - Your cancer is at a locally advanced stage (T3–T4, or any stage with lymph node involvement, but no distant spread) - You are willing to receive additional therapy (radiation and/or chemotherapy) after surgery if needed **You may NOT be eligible if...** - The cancer has spread to other parts of your body - You are pregnant or breastfeeding - You have had another cancer in the past 5 years - You have already received chemotherapy or radiation for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBlood and tumor samples

Blood samples to be obtained at consent, post-operatively, post-adjuvant treatment, and at follow-up or recurrence. Tumor samples to be obtained at surgery and at time of recurrence or post-treatment biopsy, if applicable.


Locations(1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

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NCT04099290


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