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

NCT02897427 | Active Not Recruiting

• 3 other identifiers: BCM H-49215NCI-2018-02604H-49215
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus Infection

Keywords

HPV; HPV-related oropharyngeal cancer; cancer screening; HPV-related cancers

Outcome Measures

Primary Outcomes (2)

• Cancer detection rate of the seropositive group

  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.

  Up to 5 years

• Prevalence of serum antibodies to human papillomavirus (HPV)16 E antigens

  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.

  Up to 5 years

Study Arms (1)

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; Procedure: Biospecimen Collection; Procedure: Ultrasonography

Interventions

Biomarker Analysis OTHER

Complete HPV testing

Screening (specimen collection, HPV testing)

Biospecimen Collection PROCEDURE

Undergo collection of blood and oral gargle samples

Screening (specimen collection, HPV testing)

Ultrasonography PROCEDURE

Undergo transcervical ultrasonography

Also known as: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasound, Ultrasound Imaging, Ultrasound Test, Ultrasound, Medical, US

Screening (specimen collection, HPV testing)

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants willing to have HPV test

You may qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• University of Texas Southwestern Medical Center: collaborator
• Cancer Prevention Research Institute of Texas: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Links

• Baylor College of Medicine Website

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and Oral Rinse samples will be retained.

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Erich M. Sturgis

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 13, 2016
• Study Start: March 28, 2017
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): March 28, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (1)