This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564989
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : April 17, 2024
Sponsor:
Collaborators:
Mayo Clinic
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
Oropharyngeal Squamous Cell Carcinoma Carcinoma, Squamous Cell Head and Neck Squamous Cell Carcinoma Oropharynx Squamous Cell Carcinoma

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
Actual Study Start Date : November 19, 2020
Estimated Primary Completion Date : November 2033
Estimated Study Completion Date : November 2033

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
HPV+ OPSCC Patients
Patients with p16+ squamous cell carcinoma of the oropharynx (or unknown primary) who will receive definitive cancer treatment.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with HPV+ oropharyngeal squamous cell carcinoma who will receive definitive cancer treatment.
Criteria

Inclusion Criteria:

  • ≥ 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
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564989


Contacts
Layout table for location contacts
Contact: Chris Hilliard 919-966-4432 chris_hilliard@med.unc.edu
Contact: Wendell Yarbrough, MD 919-843-7091 dell@med.unc.edu

Locations
Layout table for location information
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Dan Ma, MD    507-284-8227    ma.daniel@mayo.edu   
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Chris Hilliard    919-966-4432    chris_hilliard@med.unc.edu   
Principal Investigator: Wendell Yarbrough, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Mayo Clinic
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Layout table for investigator information
Principal Investigator: Wendell Yarbrough, MD UNC Chapel Hill
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04564989    
Other Study ID Numbers: LCCC 2044
1U01DE029754-01 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: March 2024

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Human Papillomavirus
HPV
p16
Oropharynx
OPSCC
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site