Longitudinal Cohort Study on Invasive Fungal Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Retrospective and Prospective Longitudinal Observational Study on Invasive Fungal Disease After Allogeneic Hematopoietic Stem Cell Transplantation
調査の概要
状態
詳細な説明
Invasive fungal disease refers to a severe infection caused by fungi invading human tissues, blood or body fluids, mainly affecting people with weakened immune systems. Under the background of HSCT, due to the transplantation recipients undergoing high-dose chemotherapy pretreatment, graft-versus-host disease (GVHD), and the use of immunosuppressants, the immune function of the body is severely impaired, and the risk of IFD occurrence significantly increases. The clinical manifestations of IFD after HSCT are diverse, which can involve multiple organs and systems such as the lungs, blood, central nervous system, and skin. It is difficult to diagnose, challenging to treat, and has a poor prognosis, seriously affecting the long-term survival and quality of life of transplant patients.
In recent years, the epidemiological characteristics of IFD after HSCT have undergone significant changes. According to the CAESAR 2.0 study, among 2015 Chinese patients who received allo-HSCT, the cumulative one-year incidence of IFD (proven + probable) was 6.3%. It is worth noting that compared with the CAESAR study ten years ago, the pathogen spectrum has undergone a significant transformation, which is closely related to the evolution of antifungal prevention strategies - ten years ago, fluconazole was mainly used for prevention, while currently about three quarters of patients use antifungal active drugs such as voliconazole or posaconazole. Although this shift in preventive strategies has reduced the occurrence of aspergillosis, it may increase the risk of infection from drug-resistant pathogens such as Mucor.
IFD after HSCT remains a major clinical challenge affecting the prognosis of patients. The current research has the following deficiencies: (1) There is still a lack of multi-center, large-sample prospective cohort studies in China; (2) The dynamic changes in the pathogen spectrum and clinical characteristics of IFD require continuous monitoring. (3) The diagnosis and treatment strategies and prognostic factors of different types of IFD need in-depth research. Based on the above background, this study intends to establish a longitudinal observational cohort that combines retrospective and prospective approaches to systematically evaluate the epidemiological characteristics, treatment strategies, and short-term and long-term outcomes of IFD patients after HSCT.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Jin Wu, MD
- 電話番号：086-01088326002
- メール：wujin1996@126.com
研究連絡先のバックアップ
- 名前：Fanhao Nie
- 電話番号：086-18887323790
- メール：Niefh2003@163.com
研究場所
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100044
- 募集
- Peking University People's Hospital
-
コンタクト：
- Xiaohui Zhang, MD
- 電話番号：01088326666
- メール：wujin1996@126.com
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
Study population:
Patients who underwent allo-HSCT at Peking University People's Hospital and other assistance centers since January 1, 2014.
Outcome Assessment:
Patients were followed up for the development of invasive fungal disease (IFD) after transplantation.
説明
Inclusion Criteria:
Since January 1, 2014, patients who underwent allo-HSCT at Peking University People's Hospital and other assistance centers.
Exclusion Criteria:
- For any reason, such as the occurrence of severe mental disorders, the follow-up information may be unavailable;
- Patients deemed unsuitable for the study by the researchers.
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 |
|---|
|
レトロスペクティブコホート
私たちの施設への最初の訪問とフォローアップの終了の両方が、この研究の開設前に両方とも発生した患者は、遡及的コホートに貢献します。
|
|
将来のコホート
この研究の開設後に私たちの施設を最初に訪問した患者は、将来のコホートに貢献します。
|
|
レトロスペクティブ/将来のコホート
私たちの施設を最初に訪問した患者は、この研究の開設前に発生し、この研究の開設後にフォローアップが終了する患者は、曖昧なコホートに貢献します。
|
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 |
|---|---|---|
|
Overall survival after allo-HSCT, measured as time from transplantation to death from any cause
時間枠：From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first
|
Overall survival is defined as the time from the date of allogeneic hematopoietic stem cell transplantation to death from any cause.
Participants without documented death will be censored at the date of last contact or at 5 years after transplantation, whichever occurs first.
Overall survival probabilities at 1, 3, and 5 years after transplantation will be estimated using the Kaplan-Meier method.
|
From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants with invasive fungal disease who have overall response at 1 year
時間枠：1 year after diagnosis of invasive fungal disease
|
Overall response of invasive fungal disease is defined as complete response or partial response at 1 year after diagnosis of invasive fungal disease.
Response will be assessed according to the Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria for treatment response in invasive fungal diseases.
Participants who die before the 1-year assessment or do not meet complete or partial response criteria will be classified as not having overall response.
The outcome will be summarized as the number and percentage of participants with complete or partial response.
|
1 year after diagnosis of invasive fungal disease
|
|
Cumulative incidence of proven or probable invasive fungal disease within 1 year after allo-HSCT
時間枠：From date of allo-HSCT to first diagnosis of invasive fungal disease, death, last contact, or 1 year after allo-HSCT, whichever occurs first
|
Invasive fungal disease is defined as the first episode of proven or probable invasive fungal disease after allo-HSCT according to protocol-defined diagnostic criteria based on EORTC/MSGERC definitions.
Death before invasive fungal disease will be treated as a competing event.
Participants who do not develop invasive fungal disease and do not die will be censored at the date of last contact or at 1 year after allo-HSCT, whichever occurs first.
The cumulative incidence function will be used to estimate the incidence of invasive fungal disease.
|
From date of allo-HSCT to first diagnosis of invasive fungal disease, death, last contact, or 1 year after allo-HSCT, whichever occurs first
|
|
Number and percentage of participants with post-transplant complications within 5 years after allo-HSCT
時間枠：From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first
|
Post-transplant complications include acute graft-versus-host disease, chronic graft-versus-host disease, cytomegalovirus infection or reactivation, Epstein-Barr virus infection or reactivation, bacterial bloodstream infection, organ dysfunction, relapse of the underlying hematologic disease, graft failure, intensive care unit admission.
The outcome will be summarized as the number and percentage of participants with at least one post-transplant complication and by complication category.
|
From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first
|
|
Number and percentage of participants with treatment-related adverse events as assessed by CTCAE v5.0
時間枠：From initiation of systemic antifungal therapy to 30 days after the last dose, death, or last contact, whichever occurs first
|
Treatment-related adverse events are adverse events considered related to systemic antifungal therapy.
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
The outcome will be summarized as the number and percentage of participants with at least one treatment-related adverse event.
Grade 3 or higher adverse events and serious adverse events will be summarized separately.
|
From initiation of systemic antifungal therapy to 30 days after the last dose, death, or last contact, whichever occurs first
|
|
Total length of hospital stay within 5 years after allo-HSCT, measured in inpatient days
時間枠：From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first.
|
Total length of hospital stay is defined as the cumulative number of inpatient days recorded for each participant after allogeneic hematopoietic stem cell transplantation and before death, last contact, or 5 years after transplantation, whichever occurs first.
The outcome will be summarized as inpatient days per participant using descriptive statistics.
|
From date of allo-HSCT to death, last contact, or 5 years after allo-HSCT, whichever occurs first.
|
協力者と研究者
協力者
捜査官
- 主任研究者：Xiao-Hui Zhang, MD、Peking University Institute of Hematology, Peking University People's Hospital
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
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。