Human Papillomavirus Positive Oropharyngeal Squamous Cell CarcinomaNCT03226613
New Modalities for Detection of Oropharyngeal Cancer
A study testing Transcervical Oropharyngeal Ultrasound, Oral Rinse Collection and Blood Draw in people with Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma and Oropharynx Cancer, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma, Oropharynx Cancer, Base of Tongue Carcinoma
- What is being tested?
- Transcervical Oropharyngeal Ultrasound, Oral Rinse Collection and Blood Draw
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 6 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years or older
- Suspected or confirmed oropharyngeal cancer
- Previously untreated cancer
- First cancer diagnosis
Who cannot join
- No to any of the inclusion criteria
- Under 21 years of age
- Inability to provide blood or oral rinse specimen
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37220
About this study
Official title: Advancing New Modalities for the Detection of Oropharyngeal Cancer: Transcervical Ultrasound and HPV16 E6 Antibodies
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.
Read the 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.
- Conditions
- Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma, Oropharynx Cancer, Base of Tongue Carcinoma, Tonsil Cancer
- Being tested
- Transcervical Oropharyngeal Ultrasound, Oral Rinse Collection, Blood Draw
- Keywords
- Human Papillomavirus, Oropharyngeal Cancer, Base of Tongue Cancer, Tonsil Cancer
- Medical subject headings
- Oropharyngeal Neoplasms, Tonsillar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcervical Oropharyngeal UltrasoundProcedure or surgery
Also called Phillips Lumify System (L12-4 transducer)
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.
Oral Rinse CollectionProcedure or surgery
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 DrawProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Transcervical Oropharyngeal Ultrasound; Procedure: Oral Rinse Collection; Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day at time of clinic visit
Secondary outcomes (1)
HPV Serology
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start15 Aug 2017
- Primary completion6 Jun 2018
- Study completion6 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus Positive Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Krystle Kuhs, Vanderbilt University Medical Center
- Investigators
- Krystle A Kuhs, PhD, Principal investigator, Assistant Professor for Division of Epidemiology and Department of Otolaryngology, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226613
- Sponsor's protocol ID
- 170297
- Status last verified
- Mar 2019
- First submitted
- 13 Jul 2017
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21969503Coquia 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.
PubMed 26587936Fakhry 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.
PubMed 24819862Kreimer 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.
PubMed 28376197Holzinger 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.
PubMed 28316084Lang 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.
PubMed 27010729
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing New Modalities for the Detection of Oropharyngeal Cancer: Transcervical Ultrasound and HPV16 E6 Antibodies
- ClinicalTrials.gov ID
- NCT03226613
- Acronym / sponsor ID
- 170297
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected or known oropharyngeal cancer | Experimental | Procedure: Transcervical Oropharyngeal Ultrasound, Procedure: Oral Rinse Collection, Procedure: Blood DrawPatients with either known or suspected oropharyngeal cancer will be asked to undergo a transcervical ultrasound and to provide a blood and oral rinse specimen. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 21 years or older
- Suspected or confirmed oropharyngeal cancer
- Previously untreated cancer
- First cancer diagnosis
Key exclusion criteria (3 listed)
- No to any of the inclusion criteria
- Under 21 years of age
- Inability to provide blood or oral rinse specimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcervical Oropharyngeal UltrasoundAlso: Phillips Lumify System (L12-4 transducer)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. | Procedure or surgery | Patients with suspected or known oropharyngeal cancer |
| Oral Rinse CollectionPatients 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 or surgery | Patients with suspected or known oropharyngeal cancer |
| Blood DrawA 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. | Procedure or surgery | Patients with suspected or known oropharyngeal cancer |
Primary outcome
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.
1 secondary outcome
HPV Serology
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Background: PubMed 21969503Chaturvedi 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.
- Background: PubMed 26587936Coquia 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.
- Background: PubMed 24819862Fakhry 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.
- Background: PubMed 28376197Kreimer 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.
- Background: PubMed 28316084Holzinger 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.
- Background: PubMed 27010729Lang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krystle A Kuhs, PhD principal investigator
Assistant Professor for Division of Epidemiology and Department of Otolaryngology, Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcervical Oropharyngeal Ultrasound, Oral Rinse Collection and Blood Draw in people with Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma and Oropharynx Cancer, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of tumor via transcervical ultrasound (time frame: 1 day at time of clinic visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03226613, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.