Estrogen and Gender Biased Autoimmunity | NCT00519454

Studies
Estrogen and Gender Biased Autoimmunity

NCT00519454

Sponsor

The Center for Rheumatic Disease, Allergy, & Immunology

Status

Unknown status

Last Update Posted

Sep 8, 2010Estimated

Enrollment

75Estimated

Phase

Not provided

Conditions

Systemic Lupus Erythematosus

Interventions

Peripheral lab 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

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Aug 20, 2007

First Submission Date that Met QC Criteria

Aug 21, 2007

First Posted Date

Aug 22, 2007Estimated

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

Sep 3, 2010

Last Update Posted Date

Sep 8, 2010Estimated

Name	Class
AstraZeneca	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study involves research to investigate how estrogen affects women of childbearing age and its correlation to Systemic Lupus Erythematosus. The findings from this study might help determine how body cells, called T Cells, react to estrogen. The study will seek to determine if cells from women with Lupus, react differently from cells in persons without Lupus. We will attempt to identify genetic factors that determine the effects of estrogen on Lupus cells.

Detailed Description

This is a 3-year study. The total number of subjects enrolled will depend on the results obtained. The subjects will be at least 18 years of age and pre-menopausal. Exclusion to include pregnant women, and all subjects are told not to get pregnant while on study. Also, they cannot take hormones by mouth or patch while on study. The study can include healthy subjects as well. Blood will be drawn (120 ml) four times a year, randomly.

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

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Female Lupus patients		Females who are still childbearing age, not on hormones, with Systemic Lupus Erythematosus, still cycling.	Other: Peripheral lab draws

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peripheral lab draws	Other	100ml blood for analysis, taken no more than 4 times in one year.	Female Lupus patients

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

female subjects with Lupus, and female subjects without Lupus. age at least 18, not pregnant and not planning to get pregnant.

Exclusion Criteria:

Pregnant or planning to get pregnant. On hormone replacement, or birth control of any kind.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Female subjects with SLE and still cycling, not on hormones, compared to normal controls, female subjects still cycling, also not on hormones and not diagnosed with SLE.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nabih I Abdou, MD, PhD.	Contact	816-531-0930		niabdou@centerforrheumatic.com
Cindy Greenwell, RN	Contact	816-531-0930		cindy@centerforrheumatic.com

Overall Officials

Name	Affiliation	Role
Nabih I Abdou, MD, PhD	The Center for Rheumatic Disease, Allergy and Immunology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Center for Rheumatic Disease, Allergy and Immunology	Recruiting	Kansas City	Missouri	64111	United States

Condition Browse Module

MeSH Terms

ID	Term
D008180	Lupus Erythematosus, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided