Clinical Trial: HOUSTON - HPV-related Oropharyngeal and Uncommon Cancers Screening Trial Of Men

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: HPV-Related Oropharyngeal and Uncommon Cancers Screening Trial Of Men (HOUSTON Study)

Brief Summary:

There are 2 parts in this study: pre-screening and the "main" clinical research study.

The goal of the pre-screening part of this study is to learn if participant has antibodies against human papillomavirus (HPV) . Antibodies are created by the immune system and may attack foreign cells or diseased cells, such as HPV.

The goal of the main study is to learn about the relationship between HPV and cancer risk in men who test positive for HPV antibodies. Researchers want to look for early methods of screening for certain types of cancer.

HPV infections can lead to oropharyngeal, anal, and/or penile cancer. The goal of the entire study is to learn if screening for HPV can help doctors learn which participants may be at a higher risk for developing these types of cancer.


Detailed Summary:

Pre-Screening:

If participant agrees to take part in the pre-screening part of this study, they will have the following tests and procedures at the Clinical Research Unit of the Texas Medical Center (CRU):

  • Participant will be interviewed by a member of the study staff and will be asked to complete a questionnaire about their cancer history, age, sex, race, income, smoking and alcohol drinking history, and sexual behavior. It should take around 15-20 minutes to complete.
  • Participant will also be asked to provide oral rinse samples to test for HPV. Participant will swish with a small amount of mouthwash for 15 seconds, gargle for another 15 seconds, and then spit the mouthwash into a cup.
  • Blood (about 2 teaspoons) will be drawn to test for HPV antibodies. Because the test used in this study to check for HPV antibodies is not FDA approved, participant will not be told if they have the HPV antibodies or not.

Up to 90 men who test positive for HPV antibodies and up to 90 men who test negative for HPV antibodies will be selected to take part in the main study. Participant will not be told if they are HPV-antibody positive or negative.

If participant is selected to take part in the main study, they will be given a separate consent form to sign that explains the main study in more detail, including expected tests/procedures and their risks.

If participant is not selected to be part of the main study, the study staff will contact them 1 time each year for up to 5 years to check their health status and ask about any diagnosis of cancer or other HPV-related diseases. Participant
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome:

  • Incidence Rate of HPV-Related Malignancies in Men Aged 50-59 Who Test Serologically Positive for Antibodies to HPV 16 E Antigens [ Time Frame: 5 years ]
    Researchers expect to detect 18 (95% CI 8-39) cases over 5 years in 90 men testing positive for HPV16 E antibodies, at a cumulative incidence rate of 0.2 (95% CI 0.1-0.4).
  • Incidence Rate of Oropharyngeal Related Malignancies in Men Aged 50-59 Who Test Serologically Positive for Antibodies to HPV 16 E Antigens [ Time Frame: 5 years ]
    A sample size of 90 men positive for HPV16 E antibodies will allow researchers to estimate the cumulative incidence of oropharyngeal cancer with 95% confidence with precision ± 8.3%, using the large-sample normal approximation and assuming the cumulative incidence is 20% or less (nQuery 7.0).
  • Incidence Rate of Anal Related Malignancies in Men Aged 50-59 Who Test Serologically Positive for Antibodies to HPV 16 E Antigens [ Time Frame: 5 years ]
    Given an incidence rate of anal cancer in men aged 50-59 at 2.5 (95% CI 2.4-2.6) and an estimated increased risk of 75 (95% CI 18-321), researchers expect to detect 1 (95% CI 0-4) cases over 5 years of follow up in 90 men positive for HPV16 E antibodies. A sample size of 90 men positive for HPV16 E antibodies will allow researchers to estimate the cumulative incidence of anal cancer with 95% confidence with precision +6.3% or -2.5%, using Wilson confidence interval, assuming the cumulative incidence is 4% or less.
  • Incidence Rate of Penile Related Malignancies in Men Aged 50-59 Who Test Serologically Positive for Antibodies to HPV 16 E Antigens [ Time Fram

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: September 7, 2016
    Date Started: March 28, 2017
    Date Completion: March 2027
    Last Updated: April 19, 2017
    Last Verified: April 2017