Human Epididymis Protein 4 in Normal Menstruating Women

• Sponsor: Women and Infants Hospital of Rhode Island (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01337999
• Collaborator: Abbott (Industry)
• Enrollment: 60
• Location: 1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy Premenopausal Women	Other: blood draws

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Human Epididymis Protein 4 in Normal Menstruating Women
• Study Start Date: Mar 1, 2011
• Anticipated Primary Completion Date: Jul 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. HE-4 level [5 times during menstrual cycle]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Beth Plante, Beth Plante, M.D., Women and Infants Hospital of Rhode Island
• ClinicalTrials.gov Identifier: NCT01337999
• Other Study ID Numbers: 10-0127
• First Posted: Apr 19, 2011
• Last Update Posted: Dec 17, 2013
• Last Verified: Dec 1, 2013

Study Results

No Results Posted as of Dec 17, 2013