Clinical trial · Interventional
Monitoring of Oral Human Papillomavirus Infection (HPV) in HPV-positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)
Monitoring of Oral HPV Infection in HPV-positive Oropharyngeal Squamous Cell Carcinoma During and After Chemoradiotherapy (CRT)
NCT02045186CI-TRIAL-00027353terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this research study is to determine whether and when patients with human papilloma virus positive squamous cell cancer of the oropharynx treated with radiation and chemotherapy clear their human papilloma virus infection.
Conditions
Conditions (3)
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 Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Oropharyngeal Neoplasms | Oropharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment of Oral HPV Infection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Assessment of Oral HPV Infection
- description
- Oral HPV infection will be assessed 14 times, once prior to starting CRT, weekly during CRT, and then serially post-treatment: 4-8 weeks, 3 months, 6 months, 12 months, 18 months, 24 months. Patients will provide samples of their saliva and exfoliated epithelial cells at these timepoints. Samples will be collected with supplies provided by and analyzed by OralDNA Labs.
- interventionNames
- Other: Assessment of Oral HPV Infection
Primary outcomes (1)
- measure
- Proportion of patients with HPV-positive OPSCC undergoing CRT who are clear of their oral HPV infection at each time-point
- timeFrame
- 2 years post-CRT of last enrolled patient
Secondary outcomes (3)
- measure
- Time to HPV clearance for patients with HPV-positive OPSCC undergoing CRT
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥ 18 years of age (no upper age limit) 2. AnyT, AnyN, M0 squamous cell carcinoma of the oropharynx 3. Biopsy proven squamous cell carcinoma that is HPV positive via standard pathological assessment of tumor tissues in pathology department at the treating institution 4. Scheduled for definitive CRT as primary treatment of their oropharynx cancer Exclusion Criteria: 1. Prior history of radiation therapy to the head and neck 2. Prior history of mucosal head and neck cancer. 3. Not willing or able to comply with study specific procedures
References
Publications (0)
Data not yet available
No reference posted for this study.