Human Papillomavirus in Menstrual Blood

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kidong Kim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01506128
First received: January 3, 2012
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Human Papillomavirus
Other: Collecting a Pad used at the first menstrual period after enrollment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • HPV detection rate in menstrual blood [ Time Frame: First period after enrollment usually within 2 months after enrollment ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Menstrual blood in pad


Enrollment: 19
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HPV
Premenopausal women with HSIL in Pap test or high-risk HPV
Other: Collecting a Pad used at the first menstrual period after enrollment
Collecting a Pad used at the first menstrual period after enrollment

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Suspicious cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506128

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Kidong Kim, Assistant Professor, Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01506128     History of Changes
Other Study ID Numbers: SNUBH_GO_001
Study First Received: January 3, 2012
Last Updated: March 4, 2013
Health Authority: Republic of Korea: Korean Food and Drug Administration

Keywords provided by Seoul National University Hospital:
HPV
Menstrual blood
HPV detection using menstrual blood

ClinicalTrials.gov processed this record on October 19, 2014