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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSCT Patients and Donors | Patients undergoing hematopoietic stem cell transplantation (HSCT) at Qinghai University Affiliated Hospital, and their related or unrelated stem cell donors. Participants are prospectively followed for clinical outcomes and biospecimen collection under real-world conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time 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. | From the date of HSCT until neutrophil engraftment or death, assessed up to 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From the date of HSCT until day +100, assessed up to 100 days |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with hematologic diseases undergoing hematopoietic stem cell transplantation (HSCT) and their donors at the Affiliated Hospital of Qinghai University, located in the Qinghai-Tibet Plateau. The registry systematically captures demographic, clinical, and outcome data under real-world conditions in a high-altitude environment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yigeng CAO, MD,PhD | Contact | +8618622477066 | caoyigeng@ihcams.ac.cn | |
| Hui Geng | Contact | +8618729989935 | gh0227@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Hui Geng | Affiliated Hospital of Qinghai University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Qinghai University | Recruiting | Xining | Qinghai | 810001 | China |
Individual participant data (IPD) will not be shared because the registry collects sensitive clinical and genetic information from transplant patients and donors in a high-altitude region. Data sharing may compromise patient privacy and is not permitted under current institutional and ethical committee policies. Only aggregated results will be reported publicly.
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OS is defined as time from HSCT to death from any cause. Patients alive at last follow-up will be censored. |
| 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. | 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. | 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. | 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. | From the date of HSCT until 12 months post-transplant, assessed up to 12 months |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D006467 | Hemophilia A |
| D009190 | Myelodysplastic Syndromes |
| D008223 | Lymphoma |
| D007938 | Leukemia |
| D000741 | Anemia, Aplastic |
| D020141 | Hemostatic Disorders |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001855 | Bone Marrow Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000740 | Anemia |
| D000080983 | Bone Marrow Failure Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
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