A Prognostic Tool for Early Stage CLL

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

Sponsors

Lead Sponsor: Oncology Institute of Southern Switzerland

Collaborator: Azienda Ospedaliero Universitaria Maggiore della Carita

Source 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).

Overall Status Recruiting
Start Date March 1, 2018
Completion Date February 28, 2020
Primary Completion Date February 28, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
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
Enrollment 400
Condition
Eligibility

Sampling Method: Probability Sample

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Davide Rossi, MD, PhD Principal Investigator Oncology Institute of Southern Switzerland
Overall Contact

Last Name: Davide Rossi, MD, PhD

Phone: +41 091 811 8540

Email: [email protected]

Location
Facility: Status: Contact: Azienda Ospedaliera Universitaria Maggiore della Carità Gianluca Gaidano, Prof. [email protected]
Location Countries

Italy

Verification Date

December 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Oncology Institute of Southern Switzerland

Investigator Full Name: Davide Rossi

Investigator Title: MD, PhD, Principal investigator

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Training cohort

Description: Cohort of chronic lymphocytic leukemia patients at Binet A stage for the development of the risk stratification model

Label: Validation cohort

Description: Cohort of chronic lymphocytic leukemia patients at Binet A stage for the validation of the risk stratification model

Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov