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

NCT07205523 | Recruiting

• 1 other identifier: HALO-SCT-2023
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

High-altitude Bone marrow transplantation Allogeneic HSCT Autologous HSCT Immune reconstitution Graft-versus-host disease Relapse Survival Quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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,)

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yigeng Cao,MD,PhD: lead

Study Sites (1)

Affiliated Hospital of Qinghai University

Xining, Qinghai, 810001, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Hemophilia A; Myelodysplastic Syndromes; Lymphoma; Leukemia; Anemia, Aplastic; Hemostatic Disorders; Multiple Myeloma

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Marrow Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Anemia; Bone Marrow Failure Disorders; Vascular Diseases; Cardiovascular Diseases; Neoplasms, Plasma Cell; Paraproteinemias; Blood Protein Disorders

Study Officials

• Hui Geng

  Affiliated Hospital of Qinghai University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yigeng CAO, MD,PhD

CONTACT

+8618622477066; caoyigeng@ihcams.ac.cn

Hui Geng

CONTACT

+8618729989935; gh0227@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 100 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Affiliated Hospital of Qinghai University

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: October 3, 2025
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2060
• Study Completion (Estimated): December 31, 2100
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)