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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
Oregon Health and Science University
Dana-Farber Cancer Institute
Johns Hopkins University
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: March 30, 2015
Last verified: March 2015

March 7, 2011
March 30, 2015
October 2009
December 2014   (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
    180 oropharyngeal cancer cases were enrolled including 166 with HPV-related and 14 with HPV-unrelated cancer.
  • partner or spouse of case
    104 partners of patients with oropharyngeal cancer were enrolled including 97 partners of patients with HPV-related OPC and 7 partners of patients with HPV-unrelated OPC.
  • control
    A convenience group of non-cancer controls were enrolled at some study sites at cancer screening events

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1200
May 2017
December 2014   (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
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01342978
HOTSPOT
No
Gypsyamber D'Souza, Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
  • Icahn School of Medicine at Mount Sinai
  • Oregon Health and Science University
  • Dana-Farber Cancer Institute
  • Johns Hopkins University
Principal Investigator: Gypsyamber D'Souza, PhD Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
March 2015

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