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CompletedNCT01342978HOTSPOTUpdated Mar 3, 2017

Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time

An observational study in Oropharyngeal Cancer and Human Papillomavirus, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-03.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
242
Ages
18 Years and older
Sex
All
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Study summary

This research is being done to understand more about a sexually transmitted virus called Human papillomavirus (HPV) in people with oropharyngeal cancer and their partners.

Read the detailed description

This study evaluates oral HPV infection and risk factors in people with head and neck cancer and their partners or spouses. The study focuses on oropharyngeal cancer patients and includes patients with HPV-associated and HPV-unassociated disease. A comparison group of people without cancer (controls) are also being enrolled. Couples are followed longitudinally and there is a repository of study samples. It is hoped that this research will help us understand risk factors for oral HPV infection, persistence and transmission as well as researching biomarkers for HPV-associated oral cancer and survival.

The study is led by Dr Amber D'Souza (Johns Hopkins) and laboratory testing for the study is performed in the laboratory of study co-investigator Dr Maura Gillison (Ohio University). The study biorepository is led by Dr karen Anderson (Arizona State). Participants are being enrolled at four sites across the United States including: Mt Sinai (site PI Dr Marshall Posner), Johns Hopkins (site PI Dr Sara Pai), Dana Farber Cancer Institute (site PI Dr Robert Haddad) and Oregon Health and Science University (site PI Dr Neil Gross).

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Conditions studied

  • Oropharyngeal Cancer
  • Human Papillomavirus

Keywords

  • HPV
  • HNSCC
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In context

Oropharyngeal Neoplasms

375 studies on the registry are indexed under Oropharyngeal Neoplasms; 99 are open to participants now.

This study's enrollment of 242 is above the median of 111 across 68 observational studies indexed under Oropharyngeal Neoplasms.

Browse Oropharyngeal Neoplasms studies →

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

cohort of cancer patients with matched enrollment of spouses and non-cancer controls

Inclusion criteria

  • 18 years or older and incident oropharyngeal cancer

Exclusion criteria

Exclusion Criteria:

  • Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent
  • Cancer patients with a history of organ transplant, autoimmune disorder treated with steroids or immunosuppressive drug, lymphoma, leukemia or bone marrow transplant are also ineligible (partners with these conditions are eligible)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
242 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • oropharyngeal cancer case

    208 oropharyngeal cancer cases were enrolled

  • partner or spouse of case

    110 partners of patients with oropharyngeal cancer were enrolled

  • control

    A convenience group of 106 non-cancer controls were enrolled at some study sites at cancer screening events

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What researchers measure

Primary outcomes

  1. HPV DNA detection in oral rinse sample

    Detection of 17 types of HPV DNA in exfoliated oral cells of cases and partners collected using an oral rinse and gargle

    Time frame: baseline

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Study locations

4 sites
  • Johns Hopkins Hospital
    Baltimore, Maryland 21205, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • Mt Sinai School of Medicine
    New York, New York 10029, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
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References and documents

Publications

  • Anderson KS, Wong J, D'Souza G, Riemer AB, Lorch J, Haddad R, Pai SI, Longtine J, McClean M, LaBaer J, Kelsey KT, Posner M. Serum antibodies to the HPV16 proteome as biomarkers for head and neck cancer. Br J Cancer. 2011 Jun 7;104(12):1896-905. doi: 10.1038/bjc.2011.171. PubMed 21654689 ↗
  • D'Souza G, Gross ND, Pai SI, Haddad R, Anderson KS, Rajan S, Gerber J, Gillison ML, Posner MR. Oral human papillomavirus (HPV) infection in HPV-positive patients with oropharyngeal cancer and their partners. J Clin Oncol. 2014 Aug 10;32(23):2408-15. doi: 10.1200/JCO.2014.55.1341. Epub 2014 Apr 28. PubMed 24778397 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01342978
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Icahn School of Medicine at Mount Sinai, Oregon Health and Science University, Dana-Farber Cancer Institute, Johns Hopkins University
Responsible party
Gypsyamber D'Souza (Associate Professor, Johns Hopkins Bloomberg School of Public Health) — Principal investigator
First posted
Apr 27, 2011
Start date
Oct 2009
Primary completion
Dec 2014
Completion
Jan 2017
Last update
Mar 3, 2017

Study contacts

Gypsyamber D'Souza, PhD
principal investigator · Johns Hopkins Bloomberg School of Public Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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