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
  Purpose

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.


Condition Intervention
Healthy Premenopausal Women
Other: blood draws

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Epididymis Protein 4 in Normal Menstruating Women

Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • HE-4 level [ Time Frame: 5 times during menstrual cycle ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HE-4 levels, healthy premenopausal women Other: blood draws
5 blood draws during ovulatory menstrual cycles in premenopausal women

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  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: NCT01337999

Locations
United States, Rhode Island
Women & Infants Hospital of Rhode Island, Division of Reproductive Endocrinology & Infertility
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Abbott
Investigators
Principal Investigator: Beth Plante, M.D. Women and Infants Hospital of Rhode Island
  More Information

Publications:
Responsible Party: Beth Plante, Beth Plante, M.D., Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01337999     History of Changes
Other Study ID Numbers: 10-0127
Study First Received: April 15, 2011
Last Updated: December 16, 2013
Health Authority: Women & Infants Hospital Institutional Review Board, US:
Beth Plante, M.D. - Division of Reproductive Endocrinology & Infertility at Women & Infants Hospital of Rhode Island, US:
United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 30, 2014