Clinical trial · Observational
Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oropharyngeal Squamous Cell Carcinoma | Oropharyngeal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oropharynx Squamous Cell Carcinoma | Oropharynx Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- HPV+ OPSCC Patients
- description
- Patients with p16+ squamous cell carcinoma of the oropharynx (or unknown primary) who will receive definitive cancer treatment.
Primary outcomes (5)
- measure
- Recurrence of OPSCC
- timeFrame
- From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years
- description
- 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.
- measure
- Progression-free survival
- timeFrame
- From beginning or end of treatment until date of CT-detected recurrence or date of death, assessed up to 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available