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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Affiliated Hospital of Qinghai University
Xining, Qinghai, China
RECRUITINGTime to neutrophil engraftment
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.
Time frame: From the date of HSCT until neutrophil engraftment or death, assessed up to 60 days
Incidence of acute GVHD
Proportion of patients developing grade I-IV acute GVHD, excluding events occurring after donor lymphocyte infusion (DLI). Diagnosis and grading based on consensus criteria (e.g., MAGIC).
Time frame: From the date of HSCT until day +100, assessed up to 100 days
Overall survival
OS is defined as time from HSCT to death from any cause. Patients alive at last follow-up will be censored.
Time frame: From the date of HSCT until death from any cause, assessed up to 12 months
Disease-free survival
DFS is defined as survival without relapse or progression. Patients alive without relapse at last follow-up will be censored.
Time frame: 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
Cumulative incidence of relapse/progression, with non-relapse mortality treated as a competing risk.
Time frame: From the date of HSCT until relapse/progression, assessed up to 12 months
Immune reconstitution
Serial assessment of immune reconstitution, including lymphocyte subsets, immunoglobulin recovery, and functional immune assays.
Time frame: From the date of HSCT until 12 months post-transplant, assessed at prespecified time points (e.g., day +30, +180,)
Incidence of chronic GVHD
Proportion of patients developing chronic GVHD, diagnosed and graded according to NIH 2014 consensus criteria. Death and relapse treated as competing risks.
Time frame: From the date of HSCT until 12 months post-transplant, assessed up to 12 months
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