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

Официальное название

High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT): A Prospective Real-World Cohort Study in the Qinghai-Tibet Plateau

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Time to neutrophil engraftment [Срок оценки: From the date of HSCT until neutrophil engraftment or death, assessed up to 60 days]

Вторичные конечные точки (6)

• Incidence of acute GVHD [Срок оценки: From the date of HSCT until day +100, assessed up to 100 days]
• Overall survival [Срок оценки: From the date of HSCT until death from any cause, assessed up to 12 months]
• Disease-free survival [Срок оценки: 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 [Срок оценки: From the date of HSCT until relapse/progression, assessed up to 12 months]
• Immune reconstitution [Срок оценки: From the date of HSCT until 12 months post-transplant, assessed at prespecified time points (e.g., day +30, +180,)]
• Incidence of chronic GVHD [Срок оценки: From the date of HSCT until 12 months post-transplant, assessed up to 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Affiliated Hospital of Qinghai University — Xining

Идентификаторы

NCT: NCT07205523 · HALO-SCT-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗