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

Baylor College of Medicine

Status: Active, not recruiting

Conditions: Human Papillomavirus Infection

Treatments: Other: Biomarker Analysis; Procedure: Biospecimen Collection; Procedure: Ultrasonography

Study type: Observational

Funder types: Other

Identifiers

NCT02897427

H-49215 (Other Identifier)

NCI-2018-02604 (Registry Identifier)

BCM H-49215

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: Male

Ages: 50 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

1,500 participants in 1 patient group

Screening (specimen collection, HPV testing)

Description:

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.

Treatment:

Procedure: Ultrasonography

Procedure: Biospecimen Collection

Other: Biomarker Analysis