NCT07019766

National Longitudinal Cohort of Hematological Diseases-Large Granular Lymphocytic Leukemia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 9,999 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• T-LGL Leukemia
• NK-LGL Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2000-01-01
• Primary completion: 2070-12-31
• Completion: 2070-12-31
• First posted: 2025-06-13
• Last updated: 2025-06-17

Locations

1 site across 1 country: China