A Prognostic Tool for Early Stage CLL

Completed

• Conditions: Chronic Lymphocytic Leukemia

• Registration Number: NCT03436524
• Lead Sponsor: Oncology Institute of Southern Switzerland

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-19
• Study Start: 2018-03-01
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4933

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Discrimination capacity of the study model (per c-index)	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	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).

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Maggiore della Carità; 🇮🇹 Novara, Italy