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Human Epididymis Protein 4 in Normal Menstruating Women

NCT ID: NCT01337999

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Premenopausal Women

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HE-4 levels, healthy premenopausal women

blood draws

Intervention Type OTHER

5 blood draws during ovulatory menstrual cycles in premenopausal women

Interventions

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blood draws

5 blood draws during ovulatory menstrual cycles in premenopausal women

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role lead

Responsible Party

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Beth Plante

Beth Plante, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beth Plante, M.D.

Role: PRINCIPAL_INVESTIGATOR

Women and Infants Hospital of Rhode Island

Locations

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Women & Infants Hospital of Rhode Island, Division of Reproductive Endocrinology & Infertility

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20490961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18851871 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26477497 (View on PubMed)

Other Identifiers

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10-0127

Identifier Type: -

Identifier Source: org_study_id