Human Epididymis Protein 4 in Normal Menstruating Women
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 15, 2011
CompletedFirst Posted
Study publicly available on registry
April 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedDecember 17, 2013
December 1, 2013
3.3 years
April 15, 2011
December 16, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
HE-4 level
5 times during menstrual cycle
Study Arms (1)
HE-4 levels, healthy premenopausal women
Interventions
5 blood draws during ovulatory menstrual cycles in premenopausal women
Eligibility Criteria
Ovulating women recruited from local college campuses, doctor's offices and hospitals.
You may qualify if:
- 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
You may not qualify if:
- pregnancy
- pelvic mass
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Women and Infants Hospital of Rhode Islandlead
- Abbottcollaborator
Study Sites (1)
Women & Infants Hospital of Rhode Island, Division of Reproductive Endocrinology & Infertility
Providence, Rhode Island, 02903, United States
Related Publications (3)
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.
PMID: 20490961BACKGROUNDMoore 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.
PMID: 18851871BACKGROUNDLambert-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.
PMID: 26477497DERIVED
Biospecimen
Serum
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beth Plante, M.D.
Women and Infants Hospital of Rhode Island
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Beth Plante, M.D.
Study Record Dates
First Submitted
April 15, 2011
First Posted
April 19, 2011
Study Start
March 1, 2011
Primary Completion
July 1, 2014
Last Updated
December 17, 2013
Record last verified: 2013-12