ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 42 of 207 for:    Oral Cancer | Recruiting Studies | NIH

Men and Women Offering Understanding of Throat HPV (MOUTH)

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: NCT03644563
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
Oregon Health and Science University
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief Summary:
This study will screen people for oncogenic oral Human Papillomavirus (HPV) infection and antibodies to form a cohort of people who may be at increased risk of HPV-oropharyngeal cancer (HPV-OPC). The investigators will follow these individuals prospectively to evaluate oncogenic oral HPV persistence, risk factors, and biomarkers for persistence.

Condition or disease
Oropharyngeal Cancer Human Papilloma Virus

Detailed Description:

This study will provide one of the first estimates of long-term oral HPV natural history, and the effect of biologic and behavioral risk factors, including HIV, on this natural history. Phase 1 of the study will screen approximately 3000 people for oncogenic oral HPV biomarkers. Phase 2 of the study will follow only those subjects with oncogenic oral HPV infection and/or HPV serum E6 antibodies from Phase 1 (and those previously identified as having oncogenic oral HPV infection in a previous study) with annual follow-up for oncogenic oral HPV persistence.

Understanding persistent oncogenic oral HPV infection is the focus of this study. Understanding which factors drive oral HPV infection to become persistent or progress to malignancy is critical to determine who is at high risk for oropharyngeal cancer and may benefit from screening and prevention. It is presumed that persistent oncogenic oral HPV infections are necessary for progression to HPV-OPC.

The study is led by Dr. Amber D'Souza (Johns Hopkins) and participants are being enrolled at three sites across the United States including Johns Hopkins (site Co-Is Dr. Amber D'Souza and Dr. Carole Fakhry), Icahn School of Medicine at Mt. Sinai (site PI Dr. Brett Miles) and Oregon Health and Science University (site PI Dr. Daniel Clayburgh) along with participants identified as having oncogenic oral HPV infection in a previous study.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Men and Women Offering Understanding of Throat HPV
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : June 2024

Group/Cohort
Follow-up
Those subjects with oncogenic oral HPV infection and/or HPV serum antibodies from screening (and those previously identified as having oncogenic oral HPV infection in a previous study).



Primary Outcome Measures :
  1. Oncogenic oral HPV infection present or absent in oral rinse sample [ Time Frame: Baseline to end of four year follow-up and data abstraction/linkage. ]
    To explore the effects of biologic (microbiome, oral immune response, biologic sex) risk factors for oncogenic oral HPV persistence


Secondary Outcome Measures :
  1. HPV16 E6 antibodies present or absent in serum sample [ Time Frame: Baseline to end of four year follow-up and data abstraction/linkage. ]
    To explore whether E6 seropositivity is a marker for oncogenic oral HPV persistence among high-risk groups


Biospecimen Retention:   Samples With DNA

Oral rinse sample: a sample of oral exfoliated cells will be collected using 10 mL of saline.Oral rinse samples will be tested for HPV DNA and/or RNA.

Saliva sample: Saliva sampling kits designed to preserve HPV (OraGene RNA kit from DNA Genotek) will be used to collect oral samples from all participants.

Urine sample: Urine will be tested for HPV DNA as a surrogate for genital HPV infection.

Blood collection: Each sample will be tested for antibodies to the capsid (L1) and oncoproteins (E6 and E7) of oncogenic HPV types. Capsid antibodies will be measured using virus like particle-based ELISA assays. Antibodies to the E6 and E7 proteins will be measured in a glutathione capture ELISA assays.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Target sample size: 3000 (phase 1), ~375 (phase 2) Inclusion of women and minorities: Primary enrollment is restricted to men, given their higher risk of infection (see eligibility criteria). However, the investigators expect to enroll women with women with cervical dysplasia (~125 expected women enrollees). Enrollment is across many different sources (geographically, and by clinic type), and is inclusive of diverse racial and ethnic backgrounds. Enrollment is not stratified by race but the investigators expect to enroll at least 175 minorities in the study.
Criteria

Participants in the Phase 1 Screening

Inclusion criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Male, 35- 69 years of age, with 3 or more lifetime oral sex, or
  • Women and/or partners of women with cervical dysplasia or invasive cervical cancer (ICC) or partners of HPV-positive OPC cases, who are 18 years or older, regardless of number of partners, or
  • Known oncogenic HPV-positive biomarker from prior studies or testing, regardless of number of partners.
  • Willing to be contacted to arrange follow-up visits, if determined to be eligible for phase 2
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent.
  • Participants who do not speak English cannot enroll because the consent and study survey are only available in English. However, if there is a hearing, literacy or minor fluency issue and the participant requests assistance from a family member or the study coordinator, this individual may still enroll and receive this assistance to ensure they fully hear and understand everything being asked.
  • History of head and neck cancer

Participants in the Phase 2 Follow-Up

Inclusion criteria:

  • Oncogenic oral HPV infection and/or HPV serum oncogenic antibodies detected in phase 1
  • Willingness to complete annual follow up visits

Exclusion criteria:

• Unable to complete annual follow up visits


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644563


Contacts
Contact: Amber D'Souza, PhD 4105022583 gdsouza2@jhu.edu
Contact: Tanya Troy, MPH 4432878754 ttroy2@jhu.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Amber D'Souza, PhD         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Icahn School of Medicine at Mount Sinai
Oregon Health and Science University
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Amber D'Souza, PhD Bloomberg Johns Hopkins School of Public Health

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03644563     History of Changes
Other Study ID Numbers: IRB00119537
R35DE026631 ( U.S. NIH Grant/Contract )
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Oral HPV
Persistent oncogenic HPV infection
Oropharyngeal cancer (OPC)
HPV serum E6 antibody

Additional relevant MeSH terms:
Oropharyngeal Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Papilloma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases