Estrogen and Gender Biased Autoimmunity
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Systemic Lupus Erythematosus |
Other: Peripheral lab draws |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Estrogen and Gender Biased Autoimmunity in Systemic Lupus Erythematosus |
| Estimated Enrollment: | 75 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Female Lupus patients
Females who are still childbearing age, not on hormones, with Systemic Lupus Erythematosus, still cycling.
|
Other: Peripheral lab draws
100ml blood for analysis, taken no more than 4 times in one year.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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.
Contacts and Locations| Contact: Nabih I Abdou, MD, PhD. | 816-531-0930 | niabdou@centerforrheumatic.com |
| Contact: Cindy Greenwell, RN | 816-531-0930 | cindy@centerforrheumatic.com |
| United States, Missouri | |
| The Center for Rheumatic Disease, Allergy and Immunology | Recruiting |
| Kansas City, Missouri, United States, 64111 | |
| Contact: Nabih I Abdou, MD, PhD 816-531-0930 niabdou@centerforrheumatic.com | |
| Contact: Cindy A Greenwell, RN 816-531-0930 cindy@centerforrheumatic.com | |
| Principal Investigator: Nabih I Abdou, MD, PhD | |
| Principal Investigator: | Nabih I Abdou, MD, PhD | The Center for Rheumatic Disease, Allergy and Immunology |
More Information
No publications provided
| Responsible Party: | Nabih I Abdou, Center for Rheumatic Disease Allergy & Immunology |
| ClinicalTrials.gov Identifier: | NCT00519454 History of Changes |
| Other Study ID Numbers: | 05-024 |
| Study First Received: | August 20, 2007 |
| Last Updated: | September 3, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Center for Rheumatic Disease, Allergy, & Immunology:
|
Systemic Lupus Erythematosus Estrogen receptors T cells Hormones Female adult SLE |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Estrogens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013