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
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

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on April 23, 2014