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

This study is currently recruiting participants.
Verified May 2013 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Collaborators:
Mount Sinai School of Medicine
Oregon Health and Science University
Dana-Farber Cancer Institute
Johns Hopkins Hospital (JHH)
Information provided by (Responsible Party):
Gypsyamber D'Souza, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01342978
First received: March 7, 2011
Last updated: May 1, 2013
Last verified: May 2013
History of Changes

March 7, 2011
May 1, 2013
October 2009
December 2013   (final data collection date for primary outcome measure)
HPV DNA detection in oral rinse sample [ Time Frame: baseline ] [ Designated as safety issue: No ]
Detection of 17 types of HPV DNA in exfoliated oral cells of cases and partners collected using an oral rinse and gargle
Same as current
Complete list of historical versions of study NCT01342978 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time
Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time

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.

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).
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum, oral rinse/saliva and some tumor samples
Non-Probability Sample

cohort of cancer patients with matched enrollment of spouses and non-cancer controls
  • Oropharyngeal Cancer
  • Human Papillomavirus
Not Provided
  • oropharyngeal cancer case
  • partner or spouse of case
  • control
    non-cancer controls are being enrolled at some study sites
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
May 2017
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or older and incident oropharyngeal cancer

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)
Both
18 Years and older
Yes
Not Provided
United States
 
NCT01342978
HOTSPOT
No
Gypsyamber D'Souza, Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
  • Mount Sinai School of Medicine
  • Oregon Health and Science University
  • Dana-Farber Cancer Institute
  • Johns Hopkins Hospital (JHH)
Principal Investigator: Gypsyamber D'Souza, PhD Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
May 2013

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