Throat and Other HPV-Related Cancers in Men: Identifying Them Early (TRINITY)
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ClinicalTrials.gov Identifier: NCT02897427 |
Recruitment Status :
Recruiting
First Posted : September 13, 2016
Last Update Posted : October 16, 2023
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Condition or disease | Intervention/treatment |
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Human Papillomavirus Infection | Other: Biomarker Analysis Procedure: Biospecimen Collection Procedure: Ultrasonography |
PRIMARY SCIENTIFIC OBJECTIVES:
I. 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:
I. 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 Type : | Observational |
Estimated Enrollment : | 1500 participants |
Observational Model: | Other |
Time Perspective: | Other |
Official Title: | Throat and Other HPV-Related Cancers in Men: Identifying Them Early (TRINITY Study) |
Actual Study Start Date : | March 28, 2017 |
Estimated Primary Completion Date : | March 28, 2027 |
Estimated Study Completion Date : | March 28, 2027 |
Group/Cohort | Intervention/treatment |
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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. |
Other: Biomarker Analysis
Complete HPV testing Procedure: Biospecimen Collection Undergo collection of blood and oral gargle samples Procedure: Ultrasonography Undergo transcervical ultrasonography
Other Names:
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- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 64 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897427
Contact: Samantha Redden Chirinos, MD | (713) 798-7689 | samantha.reddenchirinos@bcm.edu |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Giselle Santillana 713-798-3261 hpvtrial@bcm.edu | |
Principal Investigator: Erich Sturgis, MD, MPH |
Principal Investigator: | Erich M. Sturgis | Baylor College of Medicine |
Responsible Party: | Erich Sturgis, Professor and Vice-Chair of Clinical Affairs, Dept of Otolaryngology-Head and Neck Surgery; Brown Foundation Endowed Chair; Head, Neck, & Thyroid Cancer Multidisciplinary Program Director, Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT02897427 |
Other Study ID Numbers: |
BCM H-49215 NCI-2018-02604 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) H-49215 ( Other Identifier: Baylor College of Medicine ) |
First Posted: | September 13, 2016 Key Record Dates |
Last Update Posted: | October 16, 2023 |
Last Verified: | October 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HPV HPV-related oropharyngeal cancer cancer screening HPV-related cancers |
Papillomavirus Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Communicable Diseases Infections DNA Virus Infections |
Virus Diseases Tumor Virus Infections Genital Diseases Urogenital Diseases Disease Attributes Pathologic Processes |