A Prognostic Tool for Early Stage CLL | Clinical Trial

Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Universitaria Maggiore della Carità

Novara, 28100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Oncology Institute of Southern Switzerland

Other

Collaborators

Azienda Ospedaliero Universitaria Maggiore della Carita

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Feb 19, 2018
Registry last updated: Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed