NCT01506128

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

January 3, 2012

Last Update Submit

March 4, 2013

Conditions

Human Papillomavirus

Keywords

HPVMenstrual bloodHPV detection using menstrual blood

Outcome Measures

Primary Outcomes (1)

  • 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.

    First period after enrollment usually within 2 months after enrollment

Study Arms (1)

HPV

Premenopausal women with HSIL in Pap test or high-risk HPV

Other: Collecting a Pad used at the first menstrual period after enrollment

Interventions

Collecting a Pad used at the first menstrual period after enrollmentOTHER

Collecting a Pad used at the first menstrual period after enrollment

HPV

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Premenopausal women with HSIL at Pap test or high-risk HPV

You may qualify if:

  • Premenopausal women with HSIL at Pap test or high-risk HPV

You may not qualify if:

  • Suspicious cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Menstrual blood in pad

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 3, 2012

First Posted

January 9, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

KR(1)