A Multi-Centre Observational Prospective Cohort Study Involving the Collection of Clinical Information and Biological Specimens for the Evaluation of Novel Prognostic Tests for Myelodysplasia and Acute Myeloid Leukemia
This clinical study will provide the study specimens (samples of bone marrow and blood) and
the clinical data for a pan-Canadian collaborative research project developed by the MDS/AML
Research Consortium. The goal of this project involves the evaluation and potential
validation of five novel prognostic tests for myelodysplasia (MDS) and/or acute myeloid
leukemia (AML), as well as an analysis of health economic and socio-ethical implications
related to the potential introduction of these tests into the clinical setting. The
over-arching goal is to improve the outcomes of patients with MDS and AML. The primary
hypothesis is that one or more of the laboratory tests being evaluated in conjunction with
this study, either alone or in combination with other laboratory tests (either established
or under investigation in this project), will have statistically significant prognostic
value either alone or in combination with established clinical risk factors.
The clinical study will involve the enrollment of 200 adults with AML and 200 adults with
MDS over a 2.5 year period. Participants will be followed on study for two years. Bone
marrow and blood specimens will be collected at diagnosis and at other time points as
required for the development of the five laboratory tests.
Participants will be assigned to treatment according to local institutional practice and
will be followed for up to 2 years. Health economic and quality of life questionnaires will
be administered at key time points. Data will be collected regarding participant
characteristics, diagnosis, disease features, treatment and clinical outcome.
View this trial on ClinicalTrials.gov
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