Human Epididymis Protein 4 in Normal Menstruating Women | NCT01337999

Studies
Human Epididymis Protein 4 in Normal Menstruating Women

NCT01337999

Sponsor

Women and Infants Hospital of Rhode Island

Status

Unknown status

Last Update Posted

Dec 17, 2013Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Healthy Premenopausal Women

Interventions

blood draws

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Jul 2014Estimated

Completion Date

Not provided

First Submitted Date

Apr 15, 2011

First Submission Date that Met QC Criteria

Apr 18, 2011

First Posted Date

Apr 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2013

Last Update Posted Date

Dec 17, 2013Estimated

Name	Class
Abbott	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HE-4 levels, healthy premenopausal women			Other: blood draws

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood draws	Other	5 blood draws during ovulatory menstrual cycles in premenopausal women	HE-4 levels, healthy premenopausal women

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Beth Plante, M.D.	Women and Infants Hospital of Rhode Island	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women & Infants Hospital of Rhode Island, Division of Reproductive Endocrinology & Infertility		Providence	Rhode Island	02903	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20490961	Background	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.
18851871	Background

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis