A Prognostic Tool for Early Stage CLL

September 8, 2021 updated by: Davide Rossi, Oncology Institute of Southern Switzerland

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

4933

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Novara, Italy, 28100
        • Azienda Ospedaliera Universitaria Maggiore della Carita

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with asymptomatic chronic lymphocytic leukemia at stage Binet A.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Training cohort
Cohort of chronic lymphocytic leukemia patients at Binet A stage for the development of the risk stratification model
Validation cohorts
Cohorts of chronic lymphocytic leukemia patients at Binet A stage for the validation of the risk stratification model

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discrimination capacity of the study model (per c-index)
Time Frame: 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).
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oncology Institute of Southern Switzerland

Collaborators

Azienda Ospedaliero Universitaria Maggiore della Carita

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2018

Primary Completion (ACTUAL)

February 28, 2020

Study Completion (ACTUAL)

February 28, 2020

Study Registration Dates

First Submitted

February 12, 2018

First Submitted That Met QC Criteria

February 12, 2018

First Posted (ACTUAL)

February 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOSI-EMA-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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