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
Two of the tests involve a technology called flow cytometry. Both of the flow cytometry
tests are used to predict whether a person is likely to have a good response to chemotherapy
Three of the tests involve new genetic-based technology. One of these tests is called
comparative genomic profiling. This test can detect genetic abnormalities that current
testing methods are not able to detect. Another test involves micro-RNA profiling. The
final test involves RNA sequencing. The researchers think these tests might be useful in
predicting how well a person will respond to treatment.
The novel laboratory tests being evaluated as part of this study are still in the early
phases of development and cannot be used for clinical decision making. Participants enrolled
in this study will not be informed regarding their individual results with respect to the
study tests that are conducted using their biospecimens.
The following information (data) will be collected regarding study participants: diagnosis,
results of relevant clinical tests, age, gender, treatment and outcome during the 2 year
study follow-up period. The study also involves the completion of study questionnaires at
six different time points over the course of the two year study follow-up.
Observational Model: Cohort, Time Perspective: Prospective
Prognostic capacity of the candidate tests (alone and in combination) to predict response to treatment, time to relapse, time to death.
For the AML cohort, the candidate prognostic tests will be analyzed with adjustments for following clinical factors: age, white blood cell count at presentation, antecedent hematologic disorder, FLT-3 status, Karnofsky Performance Status (KPS), cytogenetic sub-group (using WHO 2008). For the MDS cohort the candidate prognostic tests will be analyzed with adjustments for following clinical factors: age, KPS, karyotype, bone marrow blast count and number of cytopenias at diagnosis.
Two years following the completion of enrollment.
Stephen Couban, M.D.
Capital District Health Authority, Canada
Canada: Submission of this trial to Health Canada is not required. (This has been confirmed with Health Canada.)