National Longitudinal Cohort of Hematological Diseases-Large Granular Lymphocytic Leukemia (NICHE-LGLL)

Institute of Hematology & Blood Diseases Hospital, China

Status: Enrolling

Conditions: NK-LGL Leukemia; T-LGL Leukemia

Treatments: Other: A combined retrospective and prospective observational follow-up

Study type: Observational

Funder types: Other

Identifiers

NCT07019766

IIT2025043

Details and patient eligibility

About

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.

Enrollment: 9,999 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

9,999 participants in 1 patient group

NICHE-LGLL

Description:

Patients who were diagnosed with LGLL in the investigating hospitals from Jan 1, 2000.

Treatment:

Other: A combined retrospective and prospective observational follow-up