Human Papillomavirus Infection
Conditions
Keywords
HPV, HPV-related oropharyngeal cancer, cancer screening, HPV-related cancers
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.
Interventions
OTHERBiomarker Analysis
Complete HPV testing
PROCEDUREBiospecimen Collection
Undergo collection of blood and oral gargle samples
PROCEDUREUltrasonography
Undergo transcervical ultrasonography
Sponsors
Baylor College of Medicine
University of Texas Southwestern Medical Center
Cancer Prevention Research Institute of Texas
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
MALE
Age
50 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORErich M. Sturgis
Baylor College of Medicine
Outcome results
None listed