New Modalities for Detection of Oropharyngeal Cancer

NCT03226613 | Completed

• 1 other identifier: 170297
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma; Oropharynx Cancer; Base of Tongue Carcinoma; Tonsil Cancer

Keywords

Human Papillomavirus; Oropharyngeal Cancer; Base of Tongue Cancer; Tonsil Cancer

Outcome Measures

Primary Outcomes (1)

• Detection of tumor via transcervical ultrasound

  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.

  1 day at time of clinic visit

Secondary Outcomes (1)

• HPV Serology

  Through study completion, an average of 1 year

Study Arms (1)

Patients with suspected or known oropharyngeal cancer

EXPERIMENTAL

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; Procedure: Oral Rinse Collection; Procedure: Blood Draw

Interventions

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.

Also known as: Phillips Lumify System (L12-4 transducer)

Patients with suspected or known oropharyngeal cancer

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.

Patients with suspected or known oropharyngeal cancer

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.

Patients with suspected or known oropharyngeal cancer

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Under 21 years of age
• Inability to provide blood or oral rinse specimen

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37220, United States

Location

Related Publications (6)

• Chaturvedi AK, Engels EA, Pfeiffer RM, Hernandez BY, Xiao W, Kim E, Jiang B, Goodman MT, Sibug-Saber M, Cozen W, Liu L, Lynch CF, Wentzensen N, Jordan RC, Altekruse S, Anderson WF, Rosenberg PS, Gillison ML. Human papillomavirus and rising oropharyngeal cancer incidence in the United States. J Clin Oncol. 2011 Nov 10;29(32):4294-301. doi: 10.1200/JCO.2011.36.4596. Epub 2011 Oct 3.

  PMID: 21969503 BACKGROUND

• Coquia SF, Hamper UM, Holman ME, DeJong MR, Subramaniam RM, Aygun N, Fakhry C. Visualization of the Oropharynx With Transcervical Ultrasound. AJR Am J Roentgenol. 2015 Dec;205(6):1288-94. doi: 10.2214/AJR.15.14299.

  PMID: 26587936 BACKGROUND

• Fakhry C, Agrawal N, Califano J, Messing B, Liu J, Saunders J, Ha P, Coquia S, Hamper U, Gillison M, Blanco R. The use of ultrasound in the search for the primary site of unknown primary head and neck squamous cell cancers. Oral Oncol. 2014 Jul;50(7):640-5. doi: 10.1016/j.oraloncology.2014.03.015. Epub 2014 May 10.

  PMID: 24819862 BACKGROUND

• Kreimer AR, Johansson M, Yanik EL, Katki HA, Check DP, Lang Kuhs KA, Willhauck-Fleckenstein M, Holzinger D, Hildesheim A, Pfeiffer R, Williams C, Freedman ND, Huang WY, Purdue MP, Michel A, Pawlita M, Brennan P, Waterboer T. Kinetics of the Human Papillomavirus Type 16 E6 Antibody Response Prior to Oropharyngeal Cancer. J Natl Cancer Inst. 2017 Aug 1;109(8):djx005. doi: 10.1093/jnci/djx005.

  PMID: 28376197 BACKGROUND

• Holzinger D, Wichmann G, Baboci L, Michel A, Hofler D, Wiesenfarth M, Schroeder L, Boscolo-Rizzo P, Herold-Mende C, Dyckhoff G, Boehm A, Del Mistro A, Bosch FX, Dietz A, Pawlita M, Waterboer T. Sensitivity and specificity of antibodies against HPV16 E6 and other early proteins for the detection of HPV16-driven oropharyngeal squamous cell carcinoma. Int J Cancer. 2017 Jun 15;140(12):2748-2757. doi: 10.1002/ijc.30697. Epub 2017 Apr 4.

  PMID: 28316084 BACKGROUND

• Lang Kuhs KA, Pawlita M, Gibson SP, Schmitt NC, Trivedi S, Argiris A, Kreimer AR, Ferris RL, Waterboer T. Characterization of human papillomavirus antibodies in individuals with head and neck cancer. Cancer Epidemiol. 2016 Jun;42:46-52. doi: 10.1016/j.canep.2016.03.003. Epub 2016 Mar 21.

  PMID: 27010729 BACKGROUND

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Tonsillar Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Krystle A Kuhs, PhD

  Assistant Professor for Division of Epidemiology and Department of Otolaryngology, Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 24, 2017
• Study Start: August 15, 2017
• Primary Completion: June 6, 2018
• Study Completion: June 6, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)