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Human Papillomavirus in Menstrual Blood

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01506128
First Posted: January 9, 2012
Last Update Posted: March 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kidong Kim, Seoul National University Bundang Hospital
  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 Kidong Kim, Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 3, 2012
First Posted: January 9, 2012
Last Update Posted: March 5, 2013
Last Verified: March 2013

Keywords provided by Kidong Kim, Seoul National University Bundang Hospital:
HPV
Menstrual blood
HPV detection using menstrual blood

Additional relevant MeSH terms:
Papillomavirus Infections
Squamous Intraepithelial Lesions of the Cervix
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Uterine Cervical Dysplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female