National Longitudinal Cohort of Hematological Diseases-Large Granular Lymphocytic Leukemia

NCT ID: NCT07019766

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

9999 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-01

Study Completion Date

2070-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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T-LGL Leukemia NK-LGL Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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NICHE-LGLL

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

A combined retrospective and prospective observational follow-up

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Red Blood Cell Diseases Center and Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lele Zhang, PhD

Role: CONTACT

‭15811139278‬

Facility Contacts

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Lele Zhang, PhD

Role: primary

‭15811139278‬

Other Identifiers

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IIT2025043

Identifier Type: -

Identifier Source: org_study_id

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