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New Modalities for Detection of Oropharyngeal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03226613
Recruitment Status : Completed
First Posted : July 24, 2017
Last Update Posted : March 13, 2019
American Cancer Society, Inc.
Information provided by (Responsible Party):
Krystle Kuhs, Vanderbilt University Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma Oropharynx Cancer Base of Tongue Carcinoma Tonsil Cancer Procedure: Transcervical Oropharyngeal Ultrasound Procedure: Oral Rinse Collection Procedure: Blood Draw Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Investigators conducting the ultrasound study will be masked as to the characteristics/location of patient's tumor in order to determine feasibility of identifying oropharyngeal cancers as a sole imaging technique.
Primary Purpose: Diagnostic
Official Title: Advancing New Modalities for the Detection of Oropharyngeal Cancer: Transcervical Ultrasound and HPV16 E6 Antibodies
Actual Study Start Date : August 15, 2017
Actual Primary Completion Date : June 6, 2018
Actual Study Completion Date : June 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Patients with suspected or known oropharyngeal cancer
Patients with either known or suspected oropharyngeal cancer will be asked to undergo a transcervical ultrasound and to provide a blood and oral rinse specimen.
Procedure: Transcervical Oropharyngeal Ultrasound
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 Name: Phillips Lumify System (L12-4 transducer)

Procedure: Oral Rinse Collection
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.

Procedure: Blood Draw
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 Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03226613

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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37220
Sponsors and Collaborators
Vanderbilt University Medical Center
American Cancer Society, Inc.
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Principal Investigator: Krystle A Kuhs, PhD Assistant Professor for Division of Epidemiology and Department of Otolaryngology, Vanderbilt University Medical Center


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Responsible Party: Krystle Kuhs, Assistant Professor, Vanderbilt University Medical Center Identifier: NCT03226613     History of Changes
Other Study ID Numbers: 170297
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Krystle Kuhs, Vanderbilt University Medical Center:
Human Papillomavirus
Oropharyngeal Cancer
Base of Tongue Cancer
Tonsil Cancer
Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Tonsillar Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases