High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT): A Prospective Real-World Cohort Study in the Qinghai-Tibet Plateau
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Time to neutrophil engraftment
研究概览
简要总结
The High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT) study is the first prospective real-world cohort of hematologic diseases and transplantation in the Qinghai-Tibet Plateau. Patients undergoing hematopoietic stem cell transplantation (HSCT) at Qinghai University Affiliated Hospital, together with their donors, are systematically enrolled. The registry collects demographic, diagnostic, treatment, prognosis, and medical expense information, as well as biospecimens for future analyses. Historical data are incorporated, and prospective data collection is ongoing with long-term follow-up planned. The registry is designed as a sustainable research infrastructure to provide comprehensive data on disease incidence, treatment patterns, outcomes, and resource utilization in a high-altitude setting.
详细描述
HALO-SCT is a prospective observational patient registry established at Qinghai University Affiliated Hospital, the first HSCT center in the Qinghai-Tibet Plateau. The registry aims to systematically capture patient and donor characteristics, transplant-related procedures, treatment outcomes, and long-term follow-up data in a high-altitude environment. Biospecimens, including peripheral blood and bone marrow samples, are collected at baseline and follow-up time points for future multi-omics studies. All clinical decisions follow routine practice; no experimental interventions are mandated by the protocol. The registry is intended as a long-term infrastructure project, with continuous data collection and integration into national and international collaborative research efforts.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with hematologic diseases who are admitted to the HSCT center of Qinghai University Affiliated Hospital on or after September 1,
- •Planned or actual hematopoietic stem cell transplantation (HSCT).
- •Provision of signed informed consent.
排除标准
- •Inability to provide long-term follow-up data due to severe comorbidities or logistical reasons.
- •Substance abuse compromising adherence.
- •Any condition judged by investigators to jeopardize safety or compliance.
结局指标
主要结局
Time to neutrophil engraftment
时间窗: From the date of HSCT until neutrophil engraftment or death, assessed up to 60 days
Defined as the first of 3 consecutive days with absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L without primary graft failure. Patients who die without engraftment before day +60 will be censored.
次要结局
- Incidence of acute GVHD(From the date of HSCT until day +100, assessed up to 100 days)
- Overall survival(From the date of HSCT until death from any cause, assessed up to 12 months)
- Disease-free survival(From the date of HSCT until relapse/progression or death from any cause, whichever occurs first, assessed up to 12 months)
- Cumulative incidence of relapse(From the date of HSCT until relapse/progression, assessed up to 12 months)
- Immune reconstitution(From the date of HSCT until 12 months post-transplant, assessed at prespecified time points (e.g., day +30, +180,))
- Incidence of chronic GVHD(From the date of HSCT until 12 months post-transplant, assessed up to 12 months)
研究者
Yigeng Cao,MD,PhD
Affiliated Hospital of Qinghai University
Affiliated Hospital of Qinghai University