HPV InfectionsNCT00711815
A Study to Identify Markers in Blood and Tissue of HPV Clearance
An observational study of HPV Infections, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This is a research study looking at gene characteristics in blood and Pap smear samples in hopes of identifying markers that will predict if the HPV infection is present or not. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infections
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Nov 2010
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: HPV-positive women with biopsy-confirmed CIN 1 or negative biopsies or normal colposcopic findings
Who may be able to join
- HPV positive
Who cannot join
- Negative for HPV
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35205
About this study
Official title: Biomarkers of HPV Clearance: A Prospective Study
This is a research study looking at gene characteristics in blood and Pap smear samples in hopes of identifying markers that will predict if the HPV infection is present or not.
Read the detailed description
Because infection with high-risk human papillomavirus is a necessary cause of cervical cancer, HPV testing has many potential uses in cervical cancer screening. Unfortunately, like cytology, it suffers from a lack of specificity when used for population-based screening. Given that HPV testing detects more cases of CIN3+ than cytology and that it would probably be more practical in developing regions, finding a biomarker that would increase specificity has been the goal for much research on HPV and cervical cancer. The goal of this study is to explore potential predictors of viral clearance, specifically RNA levels of candidate genes in cervical swabs and host genetic polymorphisms, in the context of genotype-specific infection data.
- Conditions
- HPV Infections
- Keywords
- Women of the state of Alabama, CIN 1, negative biopsy, normal colposcopy, HPV
- Medical subject headings
- Papillomavirus Infections
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 |
|---|---|---|
| UA | HPV positive |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJan 2007
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- Warner K Huh, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711815
- Sponsor's protocol ID
- W061101002 (UAB 0626)
- Other IDs
- 20062154 (WIRB), T06020012
- Status last verified
- Aug 2011
- First submitted
- 3 Jul 2008
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of HPV Clearance: A Prospective Study
- ClinicalTrials.gov ID
- NCT00711815
- Acronym / sponsor ID
- W061101002 (UAB 0626)
- Conditions
- HPV Infections
- Keywords
- Women of the state of Alabama, CIN 1, negative biopsy, normal colposcopy, HPV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Jul 2008 (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 is a research study looking at gene characteristics in blood and Pap smear samples in hopes of identifying markers that will predict if the HPV infection is present or not.
Detailed description
Because infection with high-risk human papillomavirus is a necessary cause of cervical cancer, HPV testing has many potential uses in cervical cancer screening. Unfortunately, like cytology, it suffers from a lack of specificity when used for population-based screening. Given that HPV testing detects more cases of CIN3+ than cytology and that it would probably be more practical in developing regions, finding a biomarker that would increase specificity has been the goal for much research on HPV and cervical cancer. The goal of this study is to explore potential predictors of viral clearance, specifically RNA levels of candidate genes in cervical swabs and host genetic polymorphisms, in the context of genotype-specific infection data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UA | – | –HPV positive |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HPV-positive women with biopsy-confirmed CIN 1 or negative biopsies or normal colposcopic findings
Key inclusion criteria (1 listed)
- HPV positive
Key exclusion criteria (1 listed)
- Negative for HPV
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
Not reported in the source record.
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 5 Aug 2011.
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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.
Warner K Huh, M.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Infections, run by University of Alabama at Birmingham at 1 site 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 1 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 5 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
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 5 Aug 2011.