NCT04099290

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators will take a piece of the tumor from the surgery and determine if they can identify mutations, or changes in the genetic makeup of the cells due to cancer, that are specific to the tumor. Based on this information, the investigators will design a test using PCR, which is a technology that allows for the amplification of the DNA, that is specific to the mutation identified in the tumor. Once verified, the presence (or absence) of ctDNA in the blood can be measured. The investigators will measure this blood test prior to surgery and at multiple time points following surgery. Specimens will be collected at the time of planned clinical assessments.

Conditions

• Head and Neck Neoplasm
• Carcinoma, Squamous Cell

Interventions

Type	Name	Description
OTHER	Blood 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.

Timeline

• Start date: 2020-01-14
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2019-09-23
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States