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NCT Number: NCT03226613

New Modalities for Detection of Oropharyngeal Cancer

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.

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Key information

Conditions

Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma Base of Tongue Carcinoma Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Oropharynx Cancer Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases Tonsil Cancer Tonsillar Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37220, United States

About this study

50 patients with suspected or confirmed OPC will undergo a transcervical ultrasound during their first visit at the Vanderbilt Head and Neck Clinic in addition to other imaging modalities (CT, MRI and/or PET) as indicated as part of routine clinical care; patients will also be asked to provide a blood specimen. Ultrasound exams will be performed by a clinician blinded to details of the case. All patients will have a CT as part of their diagnostic work-up. Sensitivity of ultrasound to detect tumors identified by CT will be determined. Approximately 40% of patients are expected to test negative on CT requiring MRI and/or PET imaging. Among this subset, the sensitivity of ultrasound to detect tumors identified by either PET and/or MRI will be determined. Tumor size will be determined by 3 ultrasound measurements along the largest diameter of the tumor; agreement between ultrasound and the clinical imaging modalities will be calculated. The investigators will recruit an additional 78 OPC patients with pre-treatment serum banked within the Vanderbilt Head and Neck Cancer Biorepository (18 HPV-negative, 60 HPV-OPC) for HPV serologic analyses; total: 128 samples. Sensitivity and specificity of HPV16 E6 antibodies for detecting HPV-OPC will be calculated. As an exploratory aim, the proportion of tumors undetectable by CT, PET, and MRI, but detected by ultrasound will be determined.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Transcervical Oropharyngeal Ultrasound

Procedure

One time approximately 15 minute ultrasound will be conducted at the time of clinic visit, focusing on the base of tongue and palatine tonsil via transcervical approach.

Other names: Phillips Lumify System (L12-4 transducer)

Oral Rinse Collection

Procedure

Patients will provide a one time oral rinse specimen using a non-alcoholic mouthwash at the time of clinic visit. The participant will be instructed to swish vigorously for 5 seconds and then gargle 5 seconds. The participant will be asked to repeated the swish and gargle (5 seconds each) three times for a total of 30 seconds and then expel the wash in a 10mL conical tube.

Blood draw

Procedure

A certified phlebotomist will perform a one time blood draw of 10mL at the time of clinic visit from each participant for purposes of HPV serologic testing.

Primary outcomes

  1. Detection of tumor via transcervical ultrasound

    Time frame: 1 day at time of clinic visit

    Ability to detect oropharyngeal tumor via ultrasound will be a primary outcome of the study. Characteristics including ability to detect tumor, tumor size, and tumor location will be recorded at time of ultrasound. The ultrasound findings will then be compared to other imaging modalities used as standard work-up (CT/MRI). This comparison will be used to determine sensitivity of ultrasound for detection of oropharyngeal tumors.

Secondary outcomes

  1. HPV Serology

    Time frame: Through study completion, an average of 1 year

    Both serum samples and oral rinse specimens will be shipped to German Cancer Research Center, Heidelberg (DKFZ) for blinded analysis of HPV antibodies. The samples will be completely de-identified prior to shipment and thus, there will be no way for the testing laboratory to link the specimens back to the patients. A random sample of blinded duplicates (10%) will be included as part of quality control. Seroreactivity against the HPV16 E6 protein will be determined using multiplex serology, an antibody detection method based on a glutathione S-transferase capture ELISA in combination with fluorescent bead technology.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Advancing New Modalities for the Detection of Oropharyngeal Cancer: Transcervical Ultrasound and HPV16 E6 Antibodies

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2017
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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