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NCT03226613 · ClinicalTrials.gov registry record · NA
New Modalities for Detection of Oropharyngeal Cancer
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
NCT03226613 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 51 participants.
The verdict
NCT03226613, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Blood Draw
- PROCEDURE Transcervical Oropharyngeal Ultrasound
- PROCEDURE Oral Rinse Collection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-08-15 |
| Est. Completion | 2018-06-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03226613
The ClinicalTrials.gov registry entry for NCT03226613 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Blood Draw is the first listed.
NCT03226613 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03226613 about?
NCT03226613 is a clinical study titled "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...
What is the current status of trial NCT03226613?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2017-08-15. Estimated completion is 2018-06-06.
What interventions are being tested in trial NCT03226613?
The interventions under investigation include: Blood Draw (PROCEDURE), Transcervical Oropharyngeal Ultrasound (PROCEDURE), Oral Rinse Collection (PROCEDURE).
Who is sponsoring clinical trial NCT03226613?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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