A Prognostic Tool for Early Stage CLL

Study Overview
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Brief Summary
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The study aims at developing a model for the prediction of time to first treatment in chronic lymphocytic leukemia patients presenting with asymptomatic early stage disease

Detailed Description
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Already existing and coded health-related personal data will be retrospectively collected from the CLL databases of the Institute of Oncology Research and of the Division of Hematology of the University of Eastern Piedmont. The adjusted association between exposure variables and time to first treatment will be estimated by Cox regression. This approach will provide the covariates independently associated with progression free survival that will be utilized in the development of a model to predict time to first treatment. Model performance (c-index and net reclassification improvement) in discriminating patients who will eventually be treated vs patients who will not be eventually treated will be compared with that of already existing prognostic model that have been validated to predict overall survival but not time to first treatment in CLL (i.e. CLL-IPI, MDACC score, Barcelona-Brno score).

Official Title
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Development of a Prognostic Tool for Predicting Prognosis in Early Stage Chronic Lymphocytic Leukemia Patients

Conditions
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Chronic Lymphocytic Leukemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adults 18 years or older Diagnosis of chronic lymphocytic leukemia Binet A stage at presentation No treatment need at presentation Availability of the baseline and follow-up annotations Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training cohort<br>Cohort of chronic lymphocytic leukemia patients at Binet A stage for the development of the risk stratification model | |
| Validation cohorts<br>Cohorts of chronic lymphocytic leukemia patients at Binet A stage for the validation of the risk stratification model | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discrimination capacity of the study model (per c-index) | Primary endpoint of the study model ability in discriminating patients who will be eventually treated vs patients who will not be eventually treated. The discrimination capacity of the model will be assessed by calculating the c-index. This approach will allow to estimate the model accuracy and its capacity of discriminating outcome at the individual patient level. Model performance (net reclassification improvement) in discriminating patients who will be eventually treated vs patients who will not be eventually treated will be compared with that of already existing prognostic models that have been validated to predict overall survival but not time to first treatment in CLL (i.e. CLL-IPI, MDACC score, Barcelona-Brno score). | Time to first treatment: interval between diagnosis and first line therapy (event), death without treatment (censoring), or last follow up without treatment (censoring), up to 20 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early stage CLL, Binet A, Prognosis