ClinicalTrials.gov record NCT07019766
National Longitudinal Cohort of Hematological Diseases-Large Granular Lymphocytic Leukemia
National Longitudinal Cohort of Hematological Diseases-Large Granular Lymphocytic Leukemia
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational cohort collects past and future medical data on people diagnosed with large granular lymphocytic leukemia (LGLL) who were treated at the Institute of Hematology and Blood Diseases Hospital from Jan 1, 2000 onward. The study will describe who gets LGLL, disease features, treatment patterns, blood-count responses, long-term outcomes, and healthcare costs. Data come from medical records, patient questionnaires, and prospective follow-up with periodic assessments.
What it is studying. The study aims to measure how often LGLL occurs and which factors are linked to it, to describe patients' clinical and laboratory features (including LGL counts, clonality, bone marrow and cytogenetics), to document treatment patterns and real-world effectiveness, and to track clinical outcomes such as hematologic response, relapse, mortality, post-treatment outcomes, and health-related quality of life. It will also collect information on healthcare costs.
What the researchers hope to learn. To estimate LGLL incidence and risk factors; to describe demographic and clinical features of LGLL; to evaluate real-world treatment patterns and hematologic responses; to assess relapse, mortality, long-term prognosis including post-discontinuation outcomes, and health-related quality of life; and to analyze healthcare costs associated with LGLL.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
- Analyze the demographic and clinical characteristics of patients with LGLL, including sex, age, disease severity, and other relevant factors.
- Examine disease features of LGLL patients, such as biochemical and hematological indicators, LGL counts, clonality, bone marrow pathology, and cytogenetics
- Assess treatment patterns and real-world effectiveness in LGLL patients.
- Evaluate clinical outcomes, including hematologic response, relapse, and mortality
- Investigate long-term prognosis, including post-discontinuation outcomes and health-related quality of life.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- A combined retrospective and prospective observational follow-up
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants permit review of their medical records to collect diagnosis, treatment, laboratory and health‑care cost information; complete questionnaires about exposures; and be followed over time for outcomes. The study combines retrospective review of past care with prospective follow‑up; assessments are scheduled at baseline, about 6, 12 and 24 months and at study completion. Diagnostic information such as LGL counts, clonality tests, and bone marrow pathology may be collected from records. The registry describes data collection from records, questionnaires, and routine clinical assessments rather than specifying new invasive study procedures.
How the study is structured. A cohort observational study that combines retrospective review of medical records with prospective follow-up. The team will collect diagnostic and treatment information and health-cost data from records, use questionnaires to capture exposures and patient-reported information, and follow patients over time to record outcomes. Hematologic response is planned to be assessed at baseline and roughly at 6, 12, and 24 months when data are available.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on large granular lymphocytic leukemia
Important dates
- Study start
- Jan 1, 2000
- Primary completion
- Dec 31, 2070 (estimated)
- Study completion
- Dec 31, 2070 (estimated)
- Target enrollment
- 9999 participants (estimated)
- Last updated on registry
- Jun 17, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Lele Zhang, PhD 📞 15811139278 ✉ zhanglele@ihcams.ac.cn
Participating sites (1)
- Red Blood Cell Diseases Center and Regenerative Medicine CenterRecruiting
Tianjin, Tianjin Municipality, 301617 · China
- Lele Zhang, PhD · 15811139278 · zhanglele@ihcams.ac.cn
Terms used on this page · explanations by MedicalUpdates.ai
- prospective cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- relapse
- A condition that improved with treatment and has since returned or worsened.
- long-term follow-up
- Observation that continues for years after the study treatment, often required for gene and cell therapies.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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