Markers of Inflammation in Hematopoietic Stem Cell Transplant
Objectives:
- To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA)
- To describe the profile of changes in inflammatory gene products, using RT-MLPA, in pediatric patients receiving stem cell transplant
- To determine if changes in a specific inflammatory product, or a combination of inflammatory products, can predict grade 2-4 acute graft-versus-host disease
調査の概要
状態
条件
詳細な説明
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) is a successful treatment option for multiple malignant diseases (i.e. leukemia) and non-malignant disorders (i.e. metabolic disorders, genetic disorders, immunodeficiencies). Unfortunately, transplantation from an HLA-related family member is only available in 30-40% of stem cell transplant recipients. The other patients requiring HSCT must then receive their stem cells from either a matched-unrelated donor (MUD) or from cord blood. One major limitation upon receiving these unrelated stem cells are acute and chronic graft-versus-host disease. Specifically looking at acute graft-versus-host disease (aGVHD), up to 30% of the recipients of stem cells from an HLA-identical related donor will develop greater or equal to grade 2 of aGVHD despite immunosuppressive prophylaxis. The percentages of patients who develop aGVHD from unrelated donors are even higher.
The current standard treatment for aGVHD is corticosteroids. Unfortunately, only 40% of matched-siblings HSCT cases and 25% of MUD SCT cases show a complete response to these steroids. Those patients who do not respond to corticosteroids can show a dismal outcome. Given the poor outcome with refractory GVHD, there has been a lot of interest in trying to predict who will get GVHD. These findings could lead to augmentation of GVHD prophylaxis.
The purpose of this study is to look at a series of identified biomarkers to predict aGVHD. Once blood is drawn from the SCT recipient, a multiplex ligation-dependent probe amplification (MLPA) will test different biomarkers in the blood to result in about 30-45 target sequences being examined simultaneously.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Illinois
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Chicago、Illinois、アメリカ、60611
- Lurie Children's Hospital
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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:
- Objective #1:
- Healthy adult volunteers, affiliated to Children's Memorial Hospital
- Male or female
- Objective #2 & #3:
- Recipient undergoing an allogeneic stem cell transplant
- Receiving related or unrelated cord blood, related or unrelated bone marrow or peripheral blood stem cells
- Any pre-transplant regimen
- Ages of 0-21 years old
- Male or female
Exclusion Criteria:
- Inability for subject/parent to understand study and therefore unable to consent
- Children under 7.0 kgs
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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1
For Objective #1:
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2
For Objectives #2 & #3:
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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 |
時間枠 |
|---|---|
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To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA)
時間枠:Until September 2008
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Until September 2008
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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To describe the profile of changes in inflammatory gene products, using RT-MLPA, in pediatric patients receiving stem cell transplant
時間枠:Until September 2008
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Until September 2008
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To determine if change in a specific inflammatory product, or a combination of inflammatory products, can predict grade 2-4 acute graft-versus-host disease
時間枠:Until September 2008
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Until September 2008
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協力者と研究者
捜査官
- 主任研究者:Reggie Duerst, MD、Ann & Robert H Lurie Children's hospital of Chicago
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
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