NCT02897427Active, not recruiting
Throat and Other HPV-Related Cancers in Men: Identifying Them Early
Throat and Other HPV-Related Cancers in Men: Identifying Them Early (TRINITY Study)
Source: ClinicalTrials.gov · Last updated 26 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 7 Sept 2016
- Start date
- 28 Mar 2017
- Primary completion date
- 28 Mar 2027
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Head and neck cancer
- NCT number
- NCT02897427
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 28 Mar 2017 to the primary completion date, 28 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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: 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
Other illness
- Stage 1 Exclusion Criteria: On active cancer therapy now or in the past 6 months
- Stage 1 Exclusion Criteria: Other medical or psychiatric illness or social situation that would limit study compliance
Other
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to 64 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.