Human Epididymis Protein 4 in Normal Menstruating Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Beth Plante, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT01337999
First received: April 15, 2011
Last updated: December 16, 2013
Last verified: December 2013

April 15, 2011
December 16, 2013
March 2011
July 2014   (final data collection date for primary outcome measure)
HE-4 level [ Time Frame: 5 times during menstrual cycle ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01337999 on ClinicalTrials.gov Archive Site
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Human Epididymis Protein 4 in Normal Menstruating Women
Human Epididymis Protein 4 in Normal Menstruating Women

The purpose of this study is to determine if Human Epididymis Protein 4 (HE-4) levels vary during the menstrual cycles in ovulatory women. HE-4 is a sensitive serological marker that is elevated in certain ovarian and endometrial cancers and can aid in the diagnosis of these malignant conditions. In order to optimize the utility of HE4 as a tumor marker in premenopausal women, its expression in the normal menstrual cycle needs to be characterized. We hypothesize that HE-4 levels do not vary in the menstrual cycle.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum

Non-Probability Sample

Ovulating women recruited from local college campuses, doctor's offices and hospitals.

Healthy Premenopausal Women
Other: blood draws
5 blood draws during ovulatory menstrual cycles in premenopausal women
HE-4 levels, healthy premenopausal women
Intervention: Other: blood draws

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
Not Provided
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • women age 18-45 years old
  • regular menstrual cycles (every 25-35 days)
  • normal BMI (19-25)
  • no hormonal contraception in the two menstrual cycles prior to enrollment

Exclusion Criteria:

  • pregnancy
  • pelvic mass
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01337999
10-0127
Yes
Beth Plante, Women and Infants Hospital of Rhode Island
Women and Infants Hospital of Rhode Island
Abbott
Principal Investigator: Beth Plante, M.D. Women and Infants Hospital of Rhode Island
Women and Infants Hospital of Rhode Island
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP