National Longitudinal Cohort of Hematological Diseases-Large Granular Lymphocytic Leukemia
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
- The protocol lists: A combined retrospective and prospective observational follow-up.
- Who it may be relevant to
- Registry conditions: T-LGL Leukemia, NK-LGL Leukemia. 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 →
Overview
Hematological diseases are disorders of the blood and hematopoietic organs. The current hematological cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in China. There is a lack of comprehensive and large-scale prospective cohort studies in hematology. The objectives of this study are to investigate the incidence and risk factors of large granular lymphocytic leukemia (LGLL) and to analyze the treatment effectiveness, patient prognosis, and healthcare costs in China. 1. Analyze the demographic and clinical characteristics of patients with LGLL, including sex, age, disease severity, and other relevant factors. 2. Examine disease features of LGLL patients, such as biochemical and hematological indicators, LGL counts, clonality, bone marrow pathology, and cytogenetics 3. Assess treatment patterns and real-world effectiveness in LGLL patients. 4. Evaluate clinical outcomes, including hematologic response, relapse, and mortality 5. Investigate long-term prognosis, including post-discontinuation outcomes and health-related quality of life.
Interventions
- Other A combined retrospective and prospective observational follow-up
The NICHE-LGLL will collect basic information, diagnostic and treatment information, as well as health costs information of patients from medical records. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information.
Primary outcome measures
- Hematologic response [Time frame: Assessments will be conducted at baseline, 6 months, 12 months, and 24 months after treatment, as well as at study completion, with an average interval of approximately 1 year.]
Eligibility criteria
Inclusion criteria
- Subjects diagnosed with LGLL.
- Subjects treated at the Institute of Hematology and Blood Diseases Hospital from Jan 1, 2000.
Exclusion criteria
- Subject unlikely to be available for long-term follow-up for any reason (e.g., inability to obtain follow-up data or presence of severe comorbidities).
- Subject with alcohol or drug dependence that may reduce their compliance with the study.
- Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study.
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
- Red Blood Cell Diseases Center and Regenerative Medicine Center — Tianjin
Identifiers
NCT: NCT07019766 · IIT2025043