Clinical trial · Observational
Throat and Other HPV-Related Cancers in Men: Identifying Them Early
Throat and Other HPV-Related Cancers in Men: Identifying Them Early (TRINITY Study)
NCT02897427CI-TRIAL-00101656TRINITYactive not recruitingClinicalTrials.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)
This trial studies the screening of human papillomavirus (HPV)-related oropharyngeal and anogenital cancers. Learning the relationship between HPV and cancer risk in men who test positive for HPV antibodies or circulating HPV DNA may help doctors to develop early methods of screening for certain types of cancer, and screening for HPV may help doctors to learn which patients may be at a higher risk for developing certain types of cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarker Analysis | Other | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Ultrasonography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Screening (specimen collection, HPV testing)
- description
- STAGE I: Participants fill out a survey and undergo collection of blood and oral rinse samples. STAGE II: Participants complete a head and neck exam by using brushing of the oropharyngeal mucosa, a thorough oropharyngeal exam including narrow band imaging, collection of oral rinse sample, transcervical ultrasonography of the neck lymph nodes and oropharynx, anoscopy, penile exam, and complete Papanicolaou/HPV testing. Participants undergo repeat oropharyngeal screening, oral HPV DNA test, oral HPV integration testing, ultrasound, and blood sample collection once every year for 5 years. Select participants will provide oral rinse sample by mail every six months.
- interventionNames
- Other: Biomarker Analysis
- Procedure: Biospecimen Collection
- Procedure: Ultrasonography
Primary outcomes (2)
- measure
- Cancer detection rate of the seropositive group
- timeFrame
- Up to 5 years
- description
- Will use the proportion equality test to compare the cancer detection rate of the seropositive group using the screening strategy with the historical rate of 0.08 (4/50). To evaluate the performance of the new techniques for early detection, will test whether the proportion of patients diagnosed at stage I, II, or III from the screening strategy is larger than the historical rate of 17.7% using the proportion equality test. Will further compute and compare the pre-cancer detection rates with the historical information.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Stage 1 Inclusion Criteria: United States (US) resident * Stage 1 Inclusion Criteria: Fluent in English * Stage 1 Inclusion Criteria: Sign an approved informed consent document * Stage 2 (longitudinal study) Inclusion Criteria: * Eligible for and enrolled in Stage 1 * Test positive to HPV16 E antibodies; be identified as a negative control; test positive for oral HPV16 infection by oral rinse; or test positive for cvDNA * Sign an approved informed consent document Exclusion Criteria: * Stage 1 Exclusion Criteria: Patients with previously documented squamous cell carcinoma of the oropharynx, anus, or penis * Stage 1 Exclusion Criteria: Received radiation cancer therapy to the head and neck in the past * Stage 1 Exclusion Criteria: On active cancer therapy now or in the past 6 months * Stage 1 Exclusion Criteria: Ever had a transplant (stem cell, bone marrow, or solid organ) * Stage 1 Exclusion Criteria: Patients who received blood transfusions in the last 6 months * Stage 1 Exclusion Criteria: Other medical or psychiatric illness or social situation that would limit study compliance * Stage 2 (longitudinal study) Exclusion Criteria: Any seronegative and cvDNA-negative man who tests negative for oral HPV16 DNA by swab and oral rinse at two consecutive follow-up visits will be excluded from further follow-up. Any man who is seropositive, cvDNA-positive, or has evidence of integration at any time will continue to be followed regardless of oral HPV16 status
References
Publications (0)
Data not yet available
No reference posted for this study.