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NCT04564989 · ClinicalTrials.gov registry record
Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
A clinical trial of Head and Neck Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- 220
- Enrollment target
- 3
- Study locations
NCT04564989: Recruiting study of Head and Neck Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT04564989 is a study of Head and Neck Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 220 participants, above the 115-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (91% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04564989, a study of Head and Neck Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- 220 participants
- Enrollment target
- 3
- Study locations
Study Summary
The primary goal of this study is to examine whether recurrence of HPV-associated OPSCC can be predicted by two factors: 1) mutations in genes called TRAF3 and CYLD, and 2) measurements of circulating HPV DNA in blood plasma. The study will also investigate whether HPV integration is associated with TRAF3 and CYLD mutations, and whether recurrence prediction improves when looking at HPV integration along with TRAF3 and CYLD mutations.
Primary Outcome
Patients will undergo post-treatment CT scans per institutional standard of care to detect cancer recurrence. Status of recurrence of OPSCC will be confirmed based on biopsy.
Conditions Studied
Study Locations (3)
Minnesota
- Mayo Clinic - Rochester
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
South Carolina
- Trident Medical Center (HCA Healthcare ) - North Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2020-11-19 |
| Est. Completion | 2033-11 |
What NCT04564989 shows while recruiting
NCT04564989 is an observational study that tracks outcomes without assigning an intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (91% higher).
The record links to 4 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 0 interventions.
NCT04564989 reports a single indexed study location in Minnesota, North Carolina, South Carolina.
Frequently Asked Questions
What is clinical trial NCT04564989 about?
NCT04564989 is a clinical study titled "Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC". The primary goal of this study is to examine whether recurrence of HPV-associated OPSCC can be predicted by two factors: 1) mutations in genes called TRAF3 and CYLD, and 2) measurements of circulating HPV DNA in blood plasma. The study will also investigate whether HPV integration is associated with...
What is the current status of trial NCT04564989?
This trial is currently recruiting. The enrollment target is 220 participants. The study started on 2020-11-19. Estimated completion is 2033-11.
What conditions does trial NCT04564989 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Carcinoma, Squamous Cell, Oropharynx Squamous Cell Carcinoma.
Who is sponsoring clinical trial NCT04564989?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04564989 being conducted?
This trial has 3 study locations across Minnesota, North Carolina, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04564989's enrollment target sits among peer trials
220 15th of 124 higher than 109 of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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