New Modalities for Detection of Oropharyngeal Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 3/15/2019 |
| Start Date: | August 15, 2017 |
| End Date: | June 6, 2018 |
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.
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.
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.
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.
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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-875-2512
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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