- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01506128
Human Papillomavirus in Menstrual Blood
March 4, 2013 updated by: Kidong Kim, Seoul National University Hospital
Exploration of Optimal Experimental Settings to Detect Human Papillomavirus From Menstrual Blood in Women With High-grade Squamous Intraepithelial Lesion or High-risk Human Papillomavirus Infection
The investigators tried to know whether a virus causing cervical cancer could be detected in menstrual blood and to set up a experimental setting to detect the virus.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Premenopausal women with HSIL at Pap test or high-risk HPV
Description
Inclusion Criteria:
- Premenopausal women with HSIL at Pap test or high-risk HPV
Exclusion Criteria:
- Suspicious cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HPV
Premenopausal women with HSIL in Pap test or high-risk HPV
|
Collecting a Pad used at the first menstrual period after enrollment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HPV detection rate in menstrual blood
Time Frame: First period after enrollment usually within 2 months after enrollment
|
The first menstrual period after enrollment is assumed to occur within 2 months.
At that time, the participant used pads and send the used pads to investigators.
The investigator do procedures to detect HPV in pads.
|
First period after enrollment usually within 2 months after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
January 3, 2012
First Submitted That Met QC Criteria
January 4, 2012
First Posted (Estimate)
January 9, 2012
Study Record Updates
Last Update Posted (Estimate)
March 5, 2013
Last Update Submitted That Met QC Criteria
March 4, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- SNUBH_GO_001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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