Oropharyngeal CancerHOTSPOTNCT01342978
Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time
An observational study of Oropharyngeal Cancer and Human Papillomavirus, run by Johns Hopkins Bloomberg School of Public Health at 4 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oropharyngeal Cancer, Human Papillomavirus
- How many people
- 242 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2009to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: cohort of cancer patients with matched enrollment of spouses and non-cancer controls
Who may be able to join
- 18 years or older and incident oropharyngeal cancer
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Mt Sinai School of Medicine
New York, New York, 10029
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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).
- Conditions
- Oropharyngeal Cancer, Human Papillomavirus
- Keywords
- HPV, HNSCC
- Medical subject headings
- Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startOct 2009
- Primary completionDec 2014
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Oregon Health and Science University, Dana-Farber Cancer Institute, Johns Hopkins University
- Responsible party
- Principal investigator, Gypsyamber D'Souza, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Gypsyamber D'Souza, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342978
- Sponsor's protocol ID
- HOTSPOT
- Acronym
- HOTSPOT
- Status last verified
- Feb 2017
- First submitted
- 7 Mar 2011
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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 21654689D'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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time
- ClinicalTrials.gov ID
- NCT01342978
- Acronym / sponsor ID
- HOTSPOT / HOTSPOT
- Conditions
- Oropharyngeal Cancer, Human Papillomavirus
- Keywords
- HPV, HNSCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Oregon Health and Science University, Dana-Farber Cancer Institute, Johns Hopkins University
- Study start
- Oct 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- cohort of cancer patients with matched enrollment of spouses and non-cancer controls
Key inclusion criteria (1 listed)
- 18 years or older and incident oropharyngeal cancer
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HPV DNA detection in oral rinse sample
Time frame: baseline
Detection of 17 types of HPV DNA in exfoliated oral cells of cases and partners collected using an oral rinse and gargle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Results publication: PubMed 21654689Anderson 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.
- Results publication: PubMed 24778397D'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gypsyamber D'Souza, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Cancer and Human Papillomavirus, run by Johns Hopkins Bloomberg School of Public Health at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV DNA detection in oral rinse sample (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01342978, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.