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临床试验/NCT06708130
NCT06708130招募中不适用

Allogeneic Hematopoietic Stem Cell Transplantation Cohort Study

Ruijin Hospital3 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
3
主要终点
Overall Survival (OS)

研究概览

简要总结

Clinical observational studies using epidemiologic theories and methods. Through the collection of various clinically relevant data, specific outcomes are evaluated in hematologic transplant patients, providing high quality real-world data for clinical practice, informing public health decision-making, and reducing the burden of disease

详细描述

This is a retrospective, prospective, two-way cohort study in which clinical diagnostic and treatment data will be collected on patients enrolled in the study and followed up to characterize the natural course of the patient population as systematically as possible. All treatment decisions and clinical assessments will be made by the treating physician based on conventional treatment criteria and are not required by the study design or protocol.

The purpose of this study is to examine the natural course of the disease and current treatments. An in-depth analysis of treatment regimens and treatment duration, as well as the sequence of regimen use, will be conducted to describe treatment modalities and healthcare expenditures for this disease state. No clinical device or laboratory/assessment interventions will be conducted except for disease management requirements based on routine practice requirements or treatment monitoring based on locally approved product characterization requirements. Patients will be required to complete a separate questionnaire containing basic epidemiologic information (demographics, disease history, environmental exposure history).

During the duration of this study, some patients may be enrolled in interventional clinical trials. This is allowed and expected to occur in this study. Patients will not be required to withdraw from the cohort study and will continue to be followed up as normal, unless the investigator/patient feels it is more appropriate to withdraw from the study. All requirements of the clinical trial in question are documented according to the trial protocol.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • At least one visit to a stem cell transplant center beginning January 1, 2021
  • Proposed to undergo or have undergone hematopoietic stem cell transplantation

排除标准

  • Long-term follow-up information for patients not available for any reason (e.g., unavailable or with serious concomitant disease) according to investigator opinion
  • Due to alcohol and drug addiction thus affecting their ability to follow the requirements of the study
  • Presence of conditions that could jeopardize patient safety or affect their adherence to the protocol, according to the investigator's opinion

结局指标

主要结局

Overall Survival (OS)

时间窗: Time Frame: through study completion, an average of 5 year

OS since enrollment

次要结局

  • Strictly complete remission (sCR)(Time Frame: through study completion, an average of 5 year)
  • Complete remission (CR)(Time Frame: through study completion, an average of 5 year)
  • Very Good Partial Relief (VGPR)(Time Frame: through study completion, an average of 5 year)
  • Partial remission (PR)(Time Frame: through study completion, an average of 5 year)
  • Minor Relief (MR)(Time Frame: through study completion, an average of 5 year)
  • Disease stabilization (SD)(Time Frame: through study completion, an average of 5 year)
  • Progression of Disease (PD)(Time Frame: through study completion, an average of 5 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hu Xiaoxia

Director of the Center for Translational Medicine

Ruijin Hospital

研究点 (3)

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