National longitudinal cohort for large granular lymphocytic leukemia (LGLL)
National Longitudinal Cohort of Hematological Diseases-Large Granular Lymphocytic Leukemia
This project will collect past and ongoing medical data to test what factors affect diagnosis, treatments, and outcomes for people in China with T-LGL or NK-LGL leukemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 9999 (estimated) |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT07019766 on ClinicalTrials.gov |
What this trial studies
This observational cohort combines retrospective chart review with prospective follow-up of patients diagnosed with large granular lymphocytic leukemia at the Institute of Hematology & Blood Diseases Hospital from January 1, 2000 onward. Researchers will record demographic and clinical characteristics, laboratory and pathology findings (including LGL counts and clonality), cytogenetics, treatments received, and healthcare resource use. The study will analyze real-world treatment patterns, hematologic responses, relapse, mortality, and associated costs. Data will be used to identify incidence, risk factors, and prognostic indicators for LGLL in the Chinese patient population.
Who should consider this trial
Good fit: Patients diagnosed with T-LGL or NK-LGL leukemia who were treated at the Institute of Hematology & Blood Diseases Hospital starting January 1, 2000 and who can provide long-term follow-up data are eligible.
Not a fit: Patients unlikely to complete long-term follow-up, those with severe comorbidities or active substance dependence that limit reliable data, or patients treated entirely outside the enrolling institute are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could help clinicians identify high-risk patients and improve treatment and follow-up decisions for people with LGLL in China.
How similar studies have performed: Previous reports are mainly single-center or small multi-center cohorts that have described LGLL features, but a large prospective national cohort of this type is largely novel in China.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tianjin, Tianjin Municipality
- Red Blood Cell Diseases Center and Regenerative Medicine Center — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Lele Zhang, PhD
- Email: zhanglele@ihcams.ac.cn
- Phone: 15811139278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.