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.

Study Overview

• Status: Unknown
• Conditions: Healthy Premenopausal Women
• Intervention / Treatment: Other: blood draws

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Women & Infants Hospital of Rhode Island, Division of Reproductive Endocrinology & Infertility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HE-4 levels, healthy premenopausal women	Other: blood draws; 5 blood draws during ovulatory menstrual cycles in premenopausal women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HE-4 level	5 times during menstrual cycle

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Collaborators: Abbott
• Investigators: Principal Investigator: Beth Plante, M.D., Women and Infants Hospital of Rhode Island

Publications and helpful links

General Publications

• Anastasi E, Granato T, Marchei GG, Viggiani V, Colaprisca B, Comploj S, Reale MG, Frati L, Midulla C. Ovarian tumor marker HE4 is differently expressed during the phases of the menstrual cycle in healthy young women. Tumour Biol. 2010 Oct;31(5):411-5. doi: 10.1007/s13277-010-0049-1. Epub 2010 May 20.
• Moore RG, McMeekin DS, Brown AK, DiSilvestro P, Miller MC, Allard WJ, Gajewski W, Kurman R, Bast RC Jr, Skates SJ. A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2009 Jan;112(1):40-6. doi: 10.1016/j.ygyno.2008.08.031. Epub 2008 Oct 12.
• Lambert-Messerlian G, Plante B, Eklund EE, Raker C, Moore RG. Levels of antimullerian hormone in serum during the normal menstrual cycle. Fertil Steril. 2016 Jan;105(1):208-13.e1. doi: 10.1016/j.fertnstert.2015.09.033. Epub 2015 Oct 23.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: April 15, 2011
• First Submitted That Met QC Criteria: April 18, 2011
• First Posted (Estimate): April 19, 2011

Study Record Updates

• Last Update Posted (Estimate): December 17, 2013
• Last Update Submitted That Met QC Criteria: December 16, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 10-0127