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 : September 2, 2021
|Condition or disease|
|Oropharyngeal Cancer Human Papilloma Virus|
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 1500 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 oncogene 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 and Dr Carole Fakhry (Johns Hopkins) and participants are being enrolled in Baltimore MD (Johns Hopkins) and in New York (Mt. Sinai).
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1500 participants|
|Target Follow-Up Duration:||4 Years|
|Official Title:||Impacting the Oral HPV Continuum: MOUTH Study (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|
Those subjects with oncogenic oral HPV infection and/or HPV oncogene serum antibodies from screening.
- 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
- 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 HPV antibodies. 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.
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
|Contact: Amber D'Souza, PhDfirstname.lastname@example.org|
|Contact: Tanya Troy, MPHemail@example.com|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Amber D'Souza, PhD|
|Principal Investigator:||Amber D'Souza, PhD||Bloomberg Johns Hopkins School of Public Health|