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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02897427
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):

September 7, 2016
September 13, 2016
November 24, 2017
March 28, 2017
March 2027   (Final data collection date for primary outcome measure)
  • Incidence Rate of HPV-Related Malignancies in Men Aged 50-64 Who Test Serologically Positive for Antibodies to HPV 16 E Antigens [ Time Frame: 5 years ]
    Researchers expect to enroll 5000 men aged 50-64, and expect that approximately 50 (1%) men will test positive for HPV16 E antibodies.
  • Incidence Rate of Oropharyngeal Related Malignancies in Men Aged 50-64 Who Test Serologically Positive for Antibodies to HPV 16 E Antigens [ Time Frame: 5 years ]
    Researchers assume that the prevalence of serum antibodies to HPV16 E antigens is 1% and the prevalence of oral HPV infection is 10% in the seronegative group. With a total of 5,000 participants, researchers will have 80% power with a 1-sided α=0.05 to detect a 12% difference of oral HPV infection prevalence between the seronegative group and seropositive group (10% vs. 22%).
  • Incidence Rate of Anal Related Malignancies in Men Aged 50-64 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 50-64 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 50-64 Who Test Serologically Positive for Antibodies to HPV 16 E Antigens [ Time Frame: 5 years ]

    Incidence rate of penile cancer estimated along with a 95% Wilson confidence interval, respectively, for the HPV negative participants from the longitudinal study. A mid-P McNemar's test used to preliminarily test for the difference in incidence rate between the matched HPV positive and negative participants.

    Researchers expect to diagnose no cases of penile cancer. These estimates are based on the current incidence rates among men aged 50-64 years in the United States and Texas.

  • 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 Frame: 5 years ]
    Incidence rate of penile cancer estimated along with a 95% Wilson confidence interval, respectively, for the HPV negative participants from the longitudinal study. A mid-P McNemar's test used to preliminarily test for the difference in incidence rate between the matched HPV positive and negative participants.
Complete list of historical versions of study NCT02897427 on ClinicalTrials.gov Archive Site
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HOUSTON - HPV-related Oropharyngeal and Uncommon Cancers Screening Trial Of Men
HPV-Related Oropharyngeal and Uncommon Cancers Screening Trial Of Men (HOUSTON Study)

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.

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).

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
  • Malignant Neoplasms of Digestive Organs
  • Malignant Neoplasms of Lip Oral Cavity and Pharynx
  • Malignant Neoplasms of Male Genital Organs
  • 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.
    Other Name: 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.
  • Active Comparator: HPV E Antibody-Negative Group
    During first study visit and then every 6 months for up to 5 years, participants screened for oropharyngeal cancer. Participants also screened for anal and penile cancer.
    Interventions:
    • Procedure: Oropharyngeal Cancer Screening
    • Procedure: Ultrasound Scans
    • Procedure: Anal Cancer Screening
    • Procedure: High-Resolution Anoscopy (HRA)
    • Procedure: Penile Cancer Screening
  • Experimental: Pre-Screening for Human Papillomavirus (HPV)
    Participants screened for human papillomavirus (HPV) .
    Interventions:
    • Behavioral: Questionnaire
    • Other: Oral Rinse Samples
    • Procedure: Blood Draw
    • Other: Follow Up
  • Experimental: HPV16 E Positive Group
    During first study visit and then every 6 months for up to 5 years, participants screened for oropharyngeal cancer. Participants also screened for anal and penile cancer.
    Interventions:
    • Procedure: Oropharyngeal Cancer Screening
    • Procedure: Ultrasound Scans
    • Procedure: Anal Cancer Screening
    • Procedure: High-Resolution Anoscopy (HRA)
    • Procedure: Penile Cancer Screening
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
March 2027
March 2027   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male
  2. Aged 50-64 at enrollment
  3. US resident
  4. Fluent in English
  5. Sign an approved informed consent document
  6. Stage 2 (longitudinal study) 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:

  1. Patients with previously documented squamous cell carcinoma of the oropharynx, anus, or penis;
  2. Received radiation cancer therapy to the head and neck in the past;
  3. On active cancer therapy now or in the past 6 months
  4. Ever had a transplant (stem cell, bone marrow, or solid organ);
  5. Patients who received blood transfusions in the last 6 months
  6. Other medical or psychiatric illness or social situation that would limit study compliance.
Sexes Eligible for Study: Male
50 Years to 64 Years   (Adult)
Yes
Contact: Erich Sturgis, MD, MPH 713-792-6920 CR_Study_Registration@mdanderson.org
United States
 
 
NCT02897427
2016-0109
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Erich Sturgis, MD, MPH M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP