Clinical trial · Observational
The SPOT-HPV Study
Characterizing the Specificity and Sensitivity of Oral TTMV-HPV DNA Testing: The SPOT-HPV Study
NCT05524025CI-TRIAL-00101281completedClinicalTrials.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 is to evaluate a new test for oral HPV DNA in saliva ('oral rinse test').
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Infection | — | UNRESOLVED | — |
| HPV Positive Oropharyngeal Squamous Cell Carcinoma | Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood TTMV-HPV DNA Test | Diagnostic Test | — | UNRESOLVED |
| Salivary TTMV-HPV DNA Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control Cohort: Adult Male Without HPV-positive throat cancer
- description
- Participants will receive 1x Salivary TTMV-HPV DNA Test. If test is negative there will not be follow up, if test is positive participants will have repeat Salivary TTMV-HPV DNA Test, a blood test and head and neck exam.
- interventionNames
- Diagnostic Test: Salivary TTMV-HPV DNA Test
- Diagnostic Test: Blood TTMV-HPV DNA Test
- label
- Case Cohort: Any Adult With HPV-positive throat cancer
- description
- Participants will receive 1x Salivary and Blood TTMV-HPV DNA Test(s).
- interventionNames
- Diagnostic Test: Salivary TTMV-HPV DNA Test
Primary outcomes (1)
- measure
- Prevalence of salivary TTMV-HPV DNA
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18+ years * Able to provide informed consent * Either one of the following: * Control cohort: Male individuals WITHOUT head and neck tumors that are, or may be, HPV-positive * Case cohort: Any individual WITH incident, untreated HPV-positive oropharynx squamous cell carcinoma Exclusion Criteria: * Unable to provide informed consent * Head and neck tumors of non-oropharynx subsites that are or may be HPV-positive, including oral cavity, sinonasal, laryngeal, hypopharyngeal, or nasopharyngeal squamous cell carcinomas
References
Publications (0)
Data not yet available
No reference posted for this study.