Houston, Texas 77030


Purpose:

This trial studies the screening of human papillomavirus (HPV)-related oropharyngeal and uncommon cancers. Learning the relationship between HPV and cancer risk in men who test positive for HPV antibodies 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.


Study summary:

PRIMARY OBJECTIVES: I. To estimate the cumulative 5-year incidence rate of HPV-related malignancies, oropharyngeal, anal, and penile cancer, in men aged 50-64 who test serologically positive for antibodies to HPV 16 E antigens. SECONDARY OBJECTIVES: I. To evaluate the association of persistent oral HPV deoxyribonucleic acid (DNA) and subsequent diagnosis of oropharyngeal cancer. II. To estimate the prevalence of serological antibodies to HPV E antigens in men aged 50-64. III. To investigate behavioral risk factors for HPV-related malignancies in men. IV. To compare the incidence rates of HPV-related malignancies, oropharyngeal, anal, and penile cancer, between the matched HPV serologically positive and negative men. EXPLORATORY OBJECTIVES: I. To evaluate the performance of serological testing of HPV, when used for screening men for HPV-related malignancies. II. To evaluate the feasibility and performance of narrow band imaging to diagnose oropharyngeal cancer. III. To evaluate the feasibility and performance of transcervical ultrasonography of the neck lymph nodes and oropharynx for early diagnosis of oropharyngeal cancer. IV. To evaluate the performance of anoscopy and HPV/cytology testing of anal swab (anal Papanicolaou [Pap]) to diagnose anal cancer. V. To determine the feasibility of nucleic acid-based techniques (circulating HPV16 DNA [cvDNA] in serum as well as oral HPV16 DNA and integrated HPV16 DNA in oral rinse and swabs) to refine high-risk group selection for screening and to facilitate oropharyngeal localization of cancers and pre-cancers within a group undergoing screening. VI. To evaluate T cell response to E2, E6, and E7 antigens as a diagnostic biomarker for HPV-related cancer. VII. To evaluate the association between oral HPV16 infection and the oral microbiota as well as factors that modify any such association. OUTLINE: STAGE I: Participants undergo collection of blood and oral gargle 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, undergo collection of oral gargle 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, and ultrasound once every 6 months for 5 years. Participants also undergo collection of blood.


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 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


NCT ID:

NCT02897427


Primary Contact:

Principal Investigator
Erich Sturgis
M.D. Anderson Cancer Center

Erich M. Sturgis
Phone: 713-792-6920
Email: esturgis@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Erich M. Sturgis
Phone: 713-792-6920

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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