High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hematopoietic Stem Cell Transplantation (HSCT), Acute Myeloid Leukemia (AML), Leukemias, Acute Myeloid, Myeloid Leukemias, Acute. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT): A Prospective Real-World Cohort Study in the Qinghai-Tibet Plateau
Overview
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.
Detailed description
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.
Primary outcome measures
- Time to neutrophil engraftment [Time frame: From the date of HSCT until neutrophil engraftment or death, assessed up to 60 days]
Secondary outcome measures (6)
- Incidence of acute GVHD [Time frame: From the date of HSCT until day +100, assessed up to 100 days]
- Overall survival [Time frame: From the date of HSCT until death from any cause, assessed up to 12 months]
- Disease-free survival [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 [Time frame: From the date of HSCT until relapse/progression, assessed up to 12 months]
- Immune reconstitution [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 [Time frame: From the date of HSCT until 12 months post-transplant, assessed up to 12 months]
Eligibility criteria
Inclusion criteria
- Patients diagnosed with hematologic diseases who are admitted to the HSCT center of Qinghai University Affiliated Hospital on or after September 1, 2023.
- Planned or actual hematopoietic stem cell transplantation (HSCT).
- Provision of signed informed consent.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Affiliated Hospital of Qinghai University — Xining
Identifiers
NCT: NCT07205523 · HALO-SCT-2023