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HPV-Related Oropharyngeal and Uncommon Cancers Screening Trial Of Men (HOUSTON Study) (NCT02897427)

The goal of this clinical research study is to learn about the relationship between human papillomavirus (HPV) and cancer risk in men who test positive for HPV antibodies. Antibodies are created by the immune system and may attack foreign cells or diseased cells, such as HPV. HPV infections can lead to oropharyngeal (throat area), anal, and/or penile cancer. The goal of the entire study is to learn if screening for HPV can help doctors learn which patients may be at a higher risk for developing these types of cancer. This is an investigational study. Up to 5000 men may be enrolled in this study. All will take part at MD Anderson.
  • Procedure: Oropharyngeal Cancer Screening
    Oropharyngeal exam performed at first study visit and then every 6 months for up to 5 years. Oropharyngeal exam performed using an imaging device that is passed through nose and shines a light on back of throat. Tonsils and back of tongue rubbed with a cotton swab to test for HPV.
    • Procedure: Ultrasound Scans
      Ultrasound scans of throat and the lymph nodes in neck to check for cancer and/or dysplasia at first study visit and then every 6 months for up to 5 years.
      • Procedure: Anal Cancer Screening
        Anal pap test to test for HPV performed at first study visit. Anal samples collected by gently swabbing the anal area with a cotton swab.
        • Procedure: High-Resolution Anoscopy (HRA)
          High-resolution anoscopy (HRA) performed at first study visit. Liquid solution of diluted acetic acid flushed into anal canal. Colposcope inserted into anus and used to take pictures of possible pre-cancerous areas.
          • Procedure: Penile Cancer Screening
            During first study visit penis rubbed with a cotton-like swab to test for HPV.
            • Behavioral: Questionnaire
              Participant completes 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.
              • Survey
            • Other: Oral Rinse Samples
              Participants swish with a small amount of mouthwash for 15 seconds, gargle for another 15 seconds, and then spit the mouthwash into a cup.
              • Procedure: Blood Draw
                Blood (about 2 teaspoons) drawn to test for HPV antibodies.
                • Other: Follow Up
                  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 may be contacted by phone, mail, or email. If called, it should last about 5 minutes.
                  Ages eligible for Study
                  50 Years to 64 Years
                  Genders eligible for Study
                  Male
                  Accepts Healthy Volunteers
                  Accepts Healthy Volunteers
                  Inclusion Criteria:
                  • 1) Eligible for and enrolled in Stage 1; 2) Test positive to HPV16 E antibodies; be identified as a negative control; or test positive for oral HPV16 infection by oral rinse; 3) Sign an approved informed consent document.
                  Exclusion Criteria:
                  • Patients with previously documented squamous cell carcinoma of the oropharynx, anus, or penis;
                  • Received radiation cancer therapy to the head and neck in the past;
                  • On active cancer therapy now or in the past 6 months
                  • Ever had a transplant (stem cell, bone marrow, or solid organ);
                  • Patients who received blood transfusions in the last 6 months
                  • Other medical or psychiatric illness or social situation that would limit study compliance.
                  If you are eligible to take part in this study, and you agree, you will be screened for cancer and/or dysplasia (a type of pre-cancerous lesion). These visits will be at MD Anderson. You may refuse taking part in any part of the screening procedures or stop taking part in this study at any time. Your first visit will be at the time you sign this consent form.

                  Oropharyngeal Cancer Screening:

                  During your first study visit and then every 6 months for up to 5 years, you will be screened for oropharyngeal cancer. At each screening:

                  - You will have a head and neck exam.

                  - Blood (about 6 teaspoons) will be drawn to test how your immune system responds to infections.

                  - You will have an oropharyngeal exam to look for anything unusual in your throat. A member of the research team will use a narrow band imaging device to look at the back of your throat. A narrow band imaging device is an ultra-thin flexible probe with a video camera on the end of it that will pass through your nose and shine a light on the back of your throat. The video will be displayed on a color TV so the researchers can look for anything unusual, such as signs of cancer.

                  - Your tonsils and the back of your tongue will be rubbed with a cotton swab to test for HPV.

                  - You will have ultrasound scans of your throat and the lymph nodes in your neck to check for cancer and/or dysplasia. To do this, an ultrasound probe will be placed on the outside of the neck.

                  Anal Cancer Screening:

                  At your first study visit:

                  - You will have an anal pap test to test for HPV. To perform this test, anal samples will be collected by gently swabbing the anal area with a cotton swab.

                  - Blood (about 6 teaspoons) will be drawn to test how your immune system responds to infections.

                  - You will have high-resolution anoscopy (HRA). HRA is an exam of the anal canal that is used to check for anal cancer and dysplasia. During the exam, a liquid solution of diluted acetic acid (normally found in vinegar) will be flushed into your anal canal to help pre-cancerous areas show up better during the exam. Then, a small tube with a camera on the end (called a colposcope) will be inserted into your anus and used to take pictures of possible pre-cancerous areas. This exam should take about 5-10 minutes. You will not be sedated for this procedure.

                  Penile Cancer Screening:

                  At your first study visit:

                  - The doctor will examine your genital area to check for anything abnormal.

                  - Urine will be collected for routine tests.

                  - Your penis will be rubbed with a cotton-like swab to test for HPV.

                  If you have an abnormal test result from any of the screening procedures, you will be referred to a doctor to discuss more testing and/or treatment options, as part of your standard care.

                  Length of Study:

                  Your participation in this study will be over after your last oropharyngeal cancer screening (about 5 years after your first study visit).

                  4 locations

                  United States (4)
                  • Arizona State University
                    recruiting
                    Tempe, Arizona, United States, 85281
                  • Rice University
                    recruiting
                    Houston, Texas, United States, 77005
                  • Clinical Research Unit (CRU) of the Texas Medical Center
                    recruiting
                    Houston, Texas, United States, 77030
                  • University of Texas MD Anderson Cancer Center
                    recruiting
                    Houston, Texas, United States, 77030
                  Status:
                  recruiting
                  Type:
                  Interventional
                  Phase:
                  -
                  Start:
                  27 March, 2017
                  Updated:
                  20 November, 2017
                  Participants:
                  5000
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