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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04564989
• Other study ID #: LCCC 2044
• Secondary ID: 1U01DE029754-01
• Status: Recruiting
• Start date: November 19, 2020
• Est. completion date: November 2033

Study information

• Verified date: March 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Chris Hilliard
• Phone: 919-966-4432
• Email: chris_hilliard[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: November 2033
• Est. primary completion date: November 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Oropharyngeal Squamous Cell Carcinoma
• Oropharynx Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Mayo Clinic, National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years
Primary	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.	From beginning or end of treatment until date of CT-detected recurrence or date of death, assessed up to 5 years
Primary	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.	Baseline to up to 5 years
Primary	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.	Baseline to up to 5 years
Primary	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.	Baseline until recurrence or up to 5 years

External Links

•   Clinical trials at UNC Lineberger