High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT)

Yigeng Cao,MD,PhD

Status: Enrolling

Conditions: Acute Myeloid Leukemia (AML); Bleeding Disorders; Leukemia; Multiple Myeloma; MDS; Myeloma, Multiple; Lymphoma; Hematopoietic Stem Cell Transplantation (HSCT); Aplastic Anemia; Myelodysplastic Syndrome; Immune Reconstitution; Bone Marrow Transplantation; Hemophilia; Leukemias, Acute Myeloid; Myeloid Leukemias, Acute

Study type: Observational

Funder types: Other

Identifiers

NCT07205523

HALO-SCT-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with hematologic diseases who are admitted to the HSCT center of Qinghai University Affiliated Hospital on or after September 1, 2023.
2. Planned or actual hematopoietic stem cell transplantation (HSCT).
3. Provision of signed informed consent.

Exclusion criteria

1. Inability to provide long-term follow-up data due to severe comorbidities or logistical reasons.
2. Substance abuse compromising adherence.
3. Any condition judged by investigators to jeopardize safety or compliance.

Trial design

1,000 participants in 1 patient group

HSCT Patients and Donors

Description:

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.