Human Papillomavirus InfectionTRINITYNCT02897427
Throat and Other HPV-Related Cancers in Men: Identifying Them Early
An observational study of Human Papillomavirus Infection, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Biomarker Analysis, Biospecimen Collection and Ultrasonography
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2017to 28 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Participants willing to have HPV test
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Throat and Other HPV-Related Cancers in Men: Identifying Them Early (TRINITY Study)
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.
Read the detailed description
PRIMARY SCIENTIFIC OBJECTIVES:
- To determine the association of antibodies to human papillomavirus type 16 (HPV16) early (E) antigens and circulating HPV16 DNA (cHPVDNA) with oral HPV16 prevalence.
II. To determine the association of antibodies to HPV16 E antigens and/or cHPVDNA with site-specific HPV16 DNA prevalence, viral persistence, or cellular transformation (cancer and pre-cancer).
III. To determine the association of 12-month persistence of oral rinse HPV16 DNA with site-specific oropharyngeal HPV16 DNA prevalence, viral persistence, or cellular transformation (cancer and pre-cancer).
EXPLORATORY SCIENTIFIC OBJECTIVE:
- To explore the use of a blood-based point-of-care assay to determine HPV16 E antibody serologic status.
OUTLINE:
STAGE I: Participants undergo collection of blood and oral rinse samples.
STAGE II: Participants complete a head and neck exam with swab 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, 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.
- Conditions
- Human Papillomavirus Infection
- Being tested
- Biomarker Analysis, Biospecimen Collection, Ultrasonography
- Keywords
- HPV, HPV-related oropharyngeal cancer, cancer screening, HPV-related cancers
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker AnalysisOther
Complete HPV testing
Biospecimen CollectionProcedure or surgery
Undergo collection of blood and oral gargle samples
UltrasonographyProcedure or surgery
Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasound
Undergo transcervical ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Screening (specimen collection, HPV testing) | 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. Receives: Other: Biomarker Analysis; Procedure: Biospecimen Collection; Procedure: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer detection rate of the seropositive group
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.
Measured: Up to 5 years
Prevalence of serum antibodies to human papillomavirus (HPV)16 E antigens
Will calculate the prevalence of serum antibodies to HPV16 E antigens along with 95% confidence intervals. Will use descriptive statistics to summarize the demographic and sexual behavior characteristics of study participants overall and by HPV16 E antibody status (positive, negative). Logistic regression models will be used to determine the association between serostatus or oral HPV infection status and demographic, socioeconomic, and behavioral factors.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start28 Mar 2017
- Primary completion28 Mar 2027 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, Cancer Prevention Research Institute of Texas
- Responsible party
- Principal investigator, Erich Sturgis, Baylor College of Medicine
- Investigators
- Erich M. Sturgis, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897427
- Sponsor's protocol ID
- BCM H-49215
- Other IDs
- NCI-2018-02604, H-49215
- Acronym
- TRINITY
- Status last verified
- Jan 2026
- First submitted
- 7 Sep 2016
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Throat and Other HPV-Related Cancers in Men: Identifying Them Early (TRINITY Study)
- ClinicalTrials.gov ID
- NCT02897427
- Acronym / sponsor ID
- TRINITY / BCM H-49215
- Conditions
- Human Papillomavirus Infection
- Keywords
- HPV, HPV-related oropharyngeal cancer, cancer screening, HPV-related cancers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, Cancer Prevention Research Institute of Texas
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 28 Mar 2027 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY SCIENTIFIC OBJECTIVES:
- To determine the association of antibodies to human papillomavirus type 16 (HPV16) early (E) antigens and circulating HPV16 DNA (cHPVDNA) with oral HPV16 prevalence.
II. To determine the association of antibodies to HPV16 E antigens and/or cHPVDNA with site-specific HPV16 DNA prevalence, viral persistence, or cellular transformation (cancer and pre-cancer).
III. To determine the association of 12-month persistence of oral rinse HPV16 DNA with site-specific oropharyngeal HPV16 DNA prevalence, viral persistence, or cellular transformation (cancer and pre-cancer).
EXPLORATORY SCIENTIFIC OBJECTIVE:
- To explore the use of a blood-based point-of-care assay to determine HPV16 E antibody serologic status.
OUTLINE:
STAGE I: Participants undergo collection of blood and oral rinse samples.
STAGE II: Participants complete a head and neck exam with swab 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, 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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (specimen collection, HPV testing) | – | Other: Biomarker Analysis, Procedure: Biospecimen Collection, Procedure: UltrasonographySTAGE 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. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants willing to have HPV test
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker AnalysisComplete HPV testing | Other | Screening (specimen collection, HPV testing) |
| Biospecimen CollectionUndergo collection of blood and oral gargle samples | Procedure or surgery | Screening (specimen collection, HPV testing) |
| UltrasonographyAlso: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, UltrasoundUndergo transcervical ultrasonography | Procedure or surgery | Screening (specimen collection, HPV testing) |
Primary outcome
Cancer detection rate of the seropositive group
Time frame: Up to 5 years
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.
Prevalence of serum antibodies to human papillomavirus (HPV)16 E antigens
Time frame: Up to 5 years
Will calculate the prevalence of serum antibodies to HPV16 E antigens along with 95% confidence intervals. Will use descriptive statistics to summarize the demographic and sexual behavior characteristics of study participants overall and by HPV16 E antibody status (positive, negative). Logistic regression models will be used to determine the association between serostatus or oral HPV infection status and demographic, socioeconomic, and behavioral factors.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Baylor College of Medicine WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erich M. Sturgis principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Infection, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer detection rate of the seropositive group (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.