Immune Reconstitution and Clinical Prognosis Following Umbilical Cord Blood Transplantation
A Prospective Study on Immune Reconstitution and Clinical Prognosis in Patients After Umbilical Cord Blood Transplantation
In this prospective randomized controlled trial of umbilical cord blood hematopoietic stem cell transplant recipients, post-transplant immune data will be collected from two groups. A composite immune risk score will be used to assess immune reconstitution for risk stratification and analyze its associations with clinical prognostic endpoints.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Yahui Feng
- 電話番号：022-23608045
- メール：fengyahui@ihcams.ac.cn
研究場所
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-
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Tianjin、中国
- 募集
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
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コンタクト：
- Yahui Feng
-
-
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
説明
Inclusion Criteria:
- Age ≥ 14 years old
- Umbilical cord blood transplant
- Patients must provide written informed consent before the start of the study procedures.
Exclusion Criteria:
- Patients who are ineligible for the study due to other factors, or who will bear great risk if they participate in the study.
- Death or loss to follow-up of the patient prior to immune reconstitution stratification
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
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Composite Immune Risk Score Stratification Notification Group
Attending physicians will receive immune reconstitution risk stratification results of patients calculated by the composite immune risk score model to guide patient health monitoring. |
Attending physicians will receive immune reconstitution risk stratification results of patients calculated by the composite immune risk score model to guide patient health monitoring. |
|
介入なし：Standard Care Control Group
No risk stratification results of patients from the composite immune risk score model will be provided to attending physicians. Patients receive standard routine care. |
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 |
|---|---|---|
|
Frequency of infection-related laboratory testing (blood culture, pathogen PCR, NGS)
時間枠：6 months post-transplant
|
Defined as the count of infection-related laboratory tests (blood culture, pathogen PCR, pathogen NGS) for each patient within 6 months after umbilical cord blood transplantation. Test counts are extracted from electronic medical records. |
6 months post-transplant
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Number of medication adjustments intended to accelerate immune reconstitution or enhance infection prophylaxis
時間枠：6 months post-transplant
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6 months post-transplant
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Number of return visits
時間枠：6 months post-transplant
|
6 months post-transplant
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Frequency of infection-related laboratory testing (blood culture, pathogen PCR, NGS)
時間枠：1 year post-transplant
|
Defined as the count of infection-related laboratory tests (blood culture, pathogen PCR, pathogen NGS) for each patient within 1 year after umbilical cord blood transplantation. Test counts are extracted from electronic medical records. |
1 year post-transplant
|
|
Number of medication adjustments intended to accelerate immune reconstitution or enhance infection prophylaxis
時間枠：1 year post-transplant
|
1 year post-transplant
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Number of return visits
時間枠：1 year post-transplant
|
1 year post-transplant
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Immune reconstitution status (quantity of T, B, NK cells and other immune subsets, and T cell clonal diversity)
時間枠：at 4, 6, 9 and 12 months post-transplant
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Defined as the quantity of T cells, B cells, NK cells and other immune subsets measured by flow cytometry, and T cell clonal diversity assessed by TCR repertoire sequencing at scheduled time points. Data are extracted from electronic medical records. |
at 4, 6, 9 and 12 months post-transplant
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Infection rate
時間枠：at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Incidence of chronic GVHD
時間枠：at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Relapse rate
時間枠：at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Survival
時間枠：at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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|
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Hospitalization rate
時間枠：at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Outpatient rate
時間枠：at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
その他の研究ID番号
- SKIRT-CB-RCT-001
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。