Molecular Mechanisms Characteristics in Systemic Lupus Erythematous Autoimmune Disease (SLE)
Immune Deregulation in Patients With SLE
It is well known that the deregulation of immune responses plays a major role in many autoimmune diseases, such as Systemic Lupus Erythematosus (SLE). The main objective of this protocol is to determine whether the expression and/or function of specific molecules are deregulated in the immune cells of patients with SLE. By examining IRF4, IRF5, IBP/Def6, SWAP-70, Rock1, Rock2, and specific signaling molecules involved in the responsiveness to sex hormones, the investigators hypothesize that the deregulation in the expression and function of these molecules will result in abnormalities in the functioning of the immune cells, which is a key factor in autoimmunity.
Peripheral blood lymphocytes from healthy controls and patients with SLE will be collected and compared in order to determine if specific immune cells (IL-17 and IL-21) are deregulated in patients with SLE and if this deregulation affects their functioning. Specifically, immune cells will be isolated from the blood and then subject to scientific testing (QPCR, Western blotting, immunofluorescence assays, ELISA and FACS analysis) to see if the expression and function of these cells is related to the mechanism behind SLE. This will be a case control study, where cases of SLE will be compared to controls of healthy volunteers to assess risk factors. As these healthy volunteers are providing samples solely for research purposes, there is no standard of care for these volunteers, with the exception of a positive HIV result during screening. The Department of Genetic Medicine will enroll healthy controls and the Hospital for Special Surgery will enroll subjects with Systemic Lupus Erythematosus (SLE) for a comparative analysis of the two cohorts. Laboratory testing on all blood samples will be done at the Hospital for Special Surgery.
調査の概要
状態
条件
詳細な説明
This will be a case control study, where cases of SLE will be compared to controls of healthy volunteers to assess risk factors. As these healthy volunteers are providing samples solely for research purposes, there is no standard of care for these volunteers, with the exception of a positive HIV result during screening. The Department of Genetic Medicine will enroll healthy controls and the Hospital for Special Surgery will enroll subjects with Systemic Lupus Erythematosus (SLE) for a comparative analysis of the two cohorts (Table I). Laboratory testing on all blood samples will be done at the Hospital for Special Surgery.
Table I. Site Recruitment1
WCMC Healthy Subjects 20 HSS Subjects with SLE 20 Total 40
研究の種類
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10021
- Weill Medical College of Cornell University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Must provide informed consent
- Males and females, age 18 years and older
- Healthy Nonsmokers
Exclusion Criteria:
If the subject has
- Rheumatic disease
- Diabetes
- SLE or lupus
- Autoimmune disease
- Active infection or pregnancy
- HIV infection
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Healthy Subjects
Overall in good health Provide informed consent Male and females, age 18 years and older Nonsmokers
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SLE Subjects
Enrolled by Hospital for Special Surgery Diagnosed with Systemic Lupus Erythematosus
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Determine the molecules that play a role in onset of SLE and autoimmune disease
時間枠：1 year
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Immune cells isolated from blood samples of healthy and SLE subjects IRF4, IRF5, IBP/Def6, SWAP-70, Rock1, Rock2 molecules expression examined through scientific testing (QPCR, Western blotting, immunofluorescence assays, ELISA and FACS analysis)
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1 year
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協力者と研究者
捜査官
- 主任研究者：Ronald G Crystal, MD、Department of Genetic Medicine
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 1311014560
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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全身性エリテマトーデスの臨床試験
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Beijing Immunochina Medical Science & Technology...まだ募集していません体系的なループスerythematosusを治療するのは困難です