Oropharyngeal Squamous Cell CarcinomaNCT04564989
Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
An observational study of Oropharyngeal Squamous Cell Carcinoma and Carcinoma, Squamous Cell, run by UNC Lineberger Comprehensive Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma, Carcinoma, Squamous Cell, Head and Neck Squamous Cell Carcinoma
- How many people
- 220 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Nov 2020to Nov 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HPV+ oropharyngeal squamous cell carcinoma who will receive definitive cancer treatment.
Who may be able to join
- ≥ 18 years of age
- T0-T2 N2a-N3 M0 or T3-T4 N0-N3 M0 (AJCC 7th edition)
- Biopsy proven squamous cell carcinoma of the oropharynx or unknown primary
- No prior therapy
- No evidence of distant metastatic disease
- p16 positive = diffuse ≥ 70% tumor cell expression, with at least moderate (2/3+) staining intensity
Show all 14Show fewer
- Planned for receipt of definitive cancer treatment
- ECOG Performance Status 0-1
- Patients must be deemed able to comply with the treatment plan and follow-up schedule.
- Patients must provide study specific informed consent prior to study entry
- Exclusion Criteria: All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation:
- Prior history of radiation therapy to the head and neck
- Prior history of head and neck cancer.
- Inadequate pre-treatment tissue sample for tumor genomic analyses
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 2 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Tuvara King, 919-966-4432, tjking@med.unc.edu
Wendell Yarbrough, MD
- Recruiting
Trident Medical Center (HCA Healthcare )
North Charleston, South Carolina, 29406
Vera Markovic, 843-998-2819, Vera.Markovic@hcahealthcare.com
David Neskey, MD, 843-998-2819, david.neskey@sarahcannon.com
- Active, not recruiting
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: LCCC 2044: 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 TRAF3 and CYLD mutations, and whether recurrence prediction improves when looking at HPV integration along with TRAF3 and CYLD mutations.
- Conditions
- Oropharyngeal Squamous Cell Carcinoma, Carcinoma, Squamous Cell, Head and Neck Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma
- Keywords
- Human Papillomavirus, HPV, p16, Oropharynx, OPSCC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HPV+ OPSCC Patients | Patients with p16+ squamous cell carcinoma of the oropharynx (or unknown primary) who will receive definitive cancer treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of OPSCC
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.
Measured: From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years
Progression-free survival
Time-to-recurrence will be defined as time lapsed from end (or start) of treatment to first date recurrence (biopsy proven occur later) is detected by CT scans, or death. Otherwise, time-to-recurrence is censored at end of study date.
Measured: From beginning or end of treatment until date of CT-detected recurrence or date of death, assessed up to 5 years
Positive Predictive Value
Positive Predictive Value (PPV) is defined as probability that patients with two consecutive positive cHPVDNA (i.e., detectable cHPVDNA) really develop OPSCC recurrence during the study period.
Measured: Baseline to up to 5 years
Negative Predictive Value
Negative Predictive Value (NPV) is defined as probability that patients without two consecutive positive cHPVDNA do not develop OPSCC recurrence during the study period.
Measured: Baseline to up to 5 years
Quality of Life questionnaire
At specified timepoints before, during, and after treatment, patients will complete a questionnaire comprised of questions from the European Organization for Research and Treatment of Cancer (EORTC) QLQ H\&N35, which is for head and neck cancer patients, and EORTC QLQ C30, which is a general cancer assessment.
Measured: Baseline until recurrence or up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start19 Nov 2020
- Primary completionNov 2033 (estimated)
- Study completionNov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Wendell Yarbrough, MD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564989
- Sponsor's protocol ID
- LCCC 2044
- Other IDs
- 1U01DE029754-01
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2020
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
- ClinicalTrials.gov ID
- NCT04564989
- Acronym / sponsor ID
- LCCC 2044
- Conditions
- Oropharyngeal Squamous Cell Carcinoma, Carcinoma, Squamous Cell, Head and Neck Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma
- Keywords
- Human Papillomavirus, HPV, p16, Oropharynx, OPSCC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Mayo Clinic, National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- Nov 2033 (estimated)
- Study completion
- Nov 2033 (estimated)
- First posted
- 25 Sep 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV+ OPSCC Patients | – | –Patients with p16+ squamous cell carcinoma of the oropharynx (or unknown primary) who will receive definitive cancer treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HPV+ oropharyngeal squamous cell carcinoma who will receive definitive cancer treatment.
Key inclusion criteria (14 listed)
- ≥ 18 years of age
- T0-T2 N2a-N3 M0 or T3-T4 N0-N3 M0 (AJCC 7th edition)
- Biopsy proven squamous cell carcinoma of the oropharynx or unknown primary
- No prior therapy
- No evidence of distant metastatic disease
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence of OPSCC
Time frame: From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years
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.
Progression-free survival
Time frame: From beginning or end of treatment until date of CT-detected recurrence or date of death, assessed up to 5 years
Time-to-recurrence will be defined as time lapsed from end (or start) of treatment to first date recurrence (biopsy proven occur later) is detected by CT scans, or death. Otherwise, time-to-recurrence is censored at end of study date.
Positive Predictive Value
Time frame: Baseline to up to 5 years
Positive Predictive Value (PPV) is defined as probability that patients with two consecutive positive cHPVDNA (i.e., detectable cHPVDNA) really develop OPSCC recurrence during the study period.
Negative Predictive Value
Time frame: Baseline to up to 5 years
Negative Predictive Value (NPV) is defined as probability that patients without two consecutive positive cHPVDNA do not develop OPSCC recurrence during the study period.
Quality of Life questionnaire
Time frame: Baseline until recurrence or up to 5 years
At specified timepoints before, during, and after treatment, patients will complete a questionnaire comprised of questions from the European Organization for Research and Treatment of Cancer (EORTC) QLQ H\&N35, which is for head and neck cancer patients, and EORTC QLQ C30, which is a general cancer assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
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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.
Wendell Yarbrough, MD principal investigator
UNC Chapel Hill
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Squamous Cell Carcinoma and Carcinoma, Squamous Cell, run by UNC Lineberger Comprehensive Cancer Center at 3 sites 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 14 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori Stravers (919-966-4432, lori_stravers@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of OPSCC (time frame: From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2026.