Human PapillomavirusNCT01506128
Human Papillomavirus in Menstrual Blood
An observational study of Human Papillomavirus, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- Collecting a Pad used at the first menstrual period after enrollment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Jan 2013
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Premenopausal women with HSIL at Pap test or high-risk HPV
Who may be able to join
- Premenopausal women with HSIL at Pap test or high-risk HPV
Who cannot join
- Suspicious cancer
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
About this study
Official title: 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.
- Conditions
- Human Papillomavirus
- Being tested
- Collecting a Pad used at the first menstrual period after enrollment
- Keywords
- HPV, Menstrual blood, HPV detection using menstrual blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting a Pad used at the first menstrual period after enrollmentOther
Collecting a Pad used at the first menstrual period after enrollment
| Study group | Role | What they receive |
|---|---|---|
| HPV | Premenopausal women with HSIL in Pap test or high-risk HPV Receives: Other: Collecting a Pad used at the first menstrual period after enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV detection rate in menstrual blood
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.
Measured: First period after enrollment usually within 2 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kidong Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506128
- Sponsor's protocol ID
- SNUBH_GO_001
- Status last verified
- Mar 2013
- First submitted
- 3 Jan 2012
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01506128
- Acronym / sponsor ID
- SNUBH_GO_001
- Conditions
- Human Papillomavirus
- Keywords
- HPV, Menstrual blood, HPV detection using menstrual blood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 Jan 2012 (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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV | – | Other: Collecting a Pad used at the first menstrual period after enrollmentPremenopausal women with HSIL in Pap test or high-risk HPV |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Premenopausal women with HSIL at Pap test or high-risk HPV
Key inclusion criteria (1 listed)
- Premenopausal women with HSIL at Pap test or high-risk HPV
Key exclusion criteria (1 listed)
- Suspicious cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collecting a Pad used at the first menstrual period after enrollmentCollecting a Pad used at the first menstrual period after enrollment | Other | HPV |
Primary outcome
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.
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 Mar 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Human Papillomavirus, run by Seoul National University Hospital at 1 site in South Korea.
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 Mar 2013. 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 South Korea. 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 detection rate in menstrual blood (time frame: First period after enrollment usually within 2 months after enrollment). It is what the study was designed to measure, not a finding.
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 Mar 2013.