Clinical trial NCT02897427: Throat and Other HPV-Related Cancers in Men: Identifying Them Early
Official title: Throat and Other HPV-Related Cancers in Men: Identifying Them Early (TRINITY Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Human Papillomavirus Infection
Keywords: HPV
HPV-related oropharyngeal cancer
cancer screening
HPV-related cancers
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
name: Cancer Prevention Research Institute of Texas
First posted: 2016-09-13
Enrollment: 1500
Sex: MALE
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants willing to have HPV test

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cancer detection rate of the seropositive group
timeFrame: Up to 5 years
measure: Prevalence of serum antibodies to human papillomavirus (HPV)16 E antigens
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Erich M. Sturgis
role: PRINCIPAL_INVESTIGATOR
References: