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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04564989
Other study ID # LCCC 2044
Secondary ID 1U01DE029754-01
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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