Human Papillomavirus in Menstrual Blood

Human Papillomavirus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506128
• Other study ID #: SNUBH_GO_001
• Status: Completed
• Phase: N/A
• First received: January 3, 2012
• Last updated: March 4, 2013
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: March 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Korean Food and Drug Administration
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Suspicious cancer

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No