New Modalities for Detection of Oropharyngeal Cancer

Completed · Not applicable

Conditions studied: Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma, Oropharynx Cancer, Base of Tongue Carcinoma, Tonsil Cancer

In brief

Background: The incidence of human papilloma virus-driven oropharyngeal cancer (HPV-OPC), a type of head and neck cancer, is rapidly increasing within the US. Currently, there are no screening methods for early detection. HPV16 E6 antibodies combined with ultrasound imaging may be a promising method for early detection of HPV-OPC. However, prior to testing HPV16 E6 antibodies and ultrasound for HPV-OPC screening, larger studies are needed to further validate the utility of these methods in the diagnostic setting among patients with suspected and/or symptomatic HPV-OPC. Objective/Hypothesis: To investigate two promising screening modalities for the detection of HPV-OPC, transcervical ultrasound and HPV16 E6 antibodies. The investigators hypothesize that both ultrasound and HPV16 E6 antibodies will be highly sensitive for the detection of symptomatic HPV-OPC. Specific Aims: (1) Determine the sensitivity of ultrasound to characterize OPC tumors compared to current standard imaging modalities among patients with suspected or confirmed OPC. (2) To determine the sensitivity and specificity of HPV16 E6 antibodies for HPV-OPC. (3) Determine the sensitivity of ultrasound to detect HPV-OPC compared to current standard imaging modalities among patients that present with a neck mass and unknown primary tumor.

Key facts

Study ID

NCT03226613

Run by

Vanderbilt University Medical Center

People needed

51

Starts

2017-08-15

Expected to finish

2018-06-06

Last updated by the study team

2019-03-13

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 21 years or older
• Suspected or confirmed oropharyngeal cancer
• Previously untreated cancer
• First cancer diagnosis

You may not qualify if…

• No to any of the inclusion criteria
• Under 21 years of age
• Inability to provide blood or oral rinse specimen

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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