Clinical trial NCT03436524: A Prognostic Tool for Early Stage CLL
Official title: Development of a Prognostic Tool for Predicting Prognosis in Early Stage Chronic Lymphocytic Leukemia Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: Early stage CLL
Binet A
Prognosis
Lead sponsor: Oncology Institute of Southern Switzerland
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero Universitaria Maggiore della Carita
First posted: 2018-02-19
Enrollment: 4933
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with asymptomatic chronic lymphocytic leukemia at stage Binet A.

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).

Eligibility 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.

Primary outcomes:
measure: Discrimination capacity of the study model (per c-index)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Azienda Ospedaliera Universitaria Maggiore della Carità
Study officials:
affiliation: Oncology Institute of Southern Switzerland
name: Davide Rossi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Condoluci A, Terzi di Bergamo L, Langerbeins P, Hoechstetter MA, Herling CD, De Paoli L, Delgado J, Rabe KG, Gentile M, Doubek M, Mauro FR, Chiodin G, Mattsson M, Bahlo J, Cutrona G, Kotaskova J, Deambrogi C, Smedby KE, Spina V, Bruscaggin A, Wu W, Moia R, Bianchi E, Gerber B, Zucca E, Gillessen S, Ghielmini M, Cavalli F, Stussi G, Hess MA, Baumann TS, Neri A, Ferrarini M, Rosenquist R, Forconi F, Foa R, Pospisilova S, Morabito F, Stilgenbauer S, Dohner H, Parikh SA, Wierda WG, Montserrat E, Gaidano G, Hallek M, Rossi D. International prognostic score for asymptomatic early-stage chronic lymphocytic leukemia. Blood. 2020 May 21;135(21):1859-1869. doi: 10.1182/blood.2019003453.