Throat and Other HPV-Related Cancers in Men: Identifying Them Early
Running, not enrolling
Conditions studied: Human Papillomavirus Infection
In brief
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.
Key facts
- Study ID
- NCT02897427
- Run by
- Baylor College of Medicine
- People needed
- 1500
- Starts
- 2017-03-28
- Expected to finish
- 2027-03-28
- Last updated by the study team
- 2026-01-26
Who can join
Age: 50 and older, up to 64. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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