Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4933 participants
OBSERVATIONAL
2018-03-01
2020-02-28
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Training cohort
Cohort of chronic lymphocytic leukemia patients at Binet A stage for the development of the risk stratification model
No interventions assigned to this group
Validation cohorts
Cohorts of chronic lymphocytic leukemia patients at Binet A stage for the validation of the risk stratification model
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Azienda Ospedaliero Universitaria Maggiore della Carita
OTHER
Oncology Institute of Southern Switzerland
OTHER
Responsible Party
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Davide Rossi
MD, PhD, Principal investigator
Principal Investigators
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Davide Rossi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oncology Institute of Southern Switzerland
Locations
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Azienda Ospedaliera Universitaria Maggiore della CaritÃ
Novara, , Italy
Countries
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References
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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.
Other Identifiers
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IOSI-EMA-005
Identifier Type: -
Identifier Source: org_study_id
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