Throat and Other HPV-Related Cancers in Men: Identifying Them Early

Recruiting

• Conditions: Human Papillomavirus Infection
• Interventions: Other: Biomarker Analysis; Procedure: Biospecimen Collection; Procedure: Ultrasonography

• Registration Number: NCT02897427
• Lead Sponsor: Baylor College of Medicine

Brief 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 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:

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Study Start: 2017-03-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-16
• Primary Completion: 2027-03-28
• Study Completion: 2027-03-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 1500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screening (specimen collection, HPV testing)	Ultrasonography	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.
Screening (specimen collection, HPV testing)	Biomarker Analysis	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.
Screening (specimen collection, HPV testing)	Biospecimen Collection	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.

Primary Outcome Measures

Name	Time	Method
Prevalence of serum antibodies to human papillomavirus (HPV)16 E antigens	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.
Cancer detection rate of the seropositive group	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.

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States