AML-MDS Novel Prognostic Tests Clinical Study
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.
Acute Myeloid Leukemia (AML)
Myelodysplastic Syndrome (MDS)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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|
- Prognostic capacity of the candidate tests (alone and in combination) to predict response to treatment, time to relapse, time to death. [ Time Frame: Two years following the completion of enrollment. ] [ Designated as safety issue: No ]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.
- Cost impact of candidate tests. [ Time Frame: Two years following the completion of enrollment. ] [ Designated as safety issue: No ]The cost-effectiveness of the candidate tests for AML and MDS treatment will be projected with the aid of economic simulation models.
- Societal risks and benefits related to the candidate tests. [ Time Frame: Two years following the completion of enrollment. ] [ Designated as safety issue: No ]A comparative analysis of policies and regulations in Canada governing prognostic tests will be undertaken (including tests that utilize RNA and DNA based technologies). In addition, input will be obtained from key stakeholders. This information will be used to develop a set of guidelines and best practices for this type of research.
Biospecimen Retention: Samples With DNA
Some of the laboratory tests that will be evaluated as part of this study will utilize RNA and/or DNA. There may be biospecimens left over after the work related to this study is complete. At the time of consent for the study, participants will be asked to provide consent (or decline their consent) regarding the use of leftover specimens (including RNA and DNA) for other research. The details regarding this other research are provided in the protocol and consent template.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||February 2017|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
This cohort is comprised of participants who have acute myelogenous leukemia (AML).
This cohort is comprised of participants who have myelodysplastic syndrome (MDS).
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 or not.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685619
|Contact: Stephen Couban, M.D.||902-473-8562||Stephen.Couban@cdha.nshealth.ca|
|Contact: Holly Kerr, B.A.||604-875-4111 ext firstname.lastname@example.org|
|Tom Baker Cancer Centre||Not yet recruiting|
|Calgary, Alberta, Canada, T2N 4N2|
|Contact: Lynn Savoie, M.D. 403-944-1880 Lynn.Savoie@albertahealthservices.ca|
|Principal Investigator: Lynn Savoie, M.D.|
|Canada, British Columbia|
|Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E3|
|Contact: Donna Hogge, M.D., Ph.D. 604-875-4863 email@example.com|
|Contact: Holly Kerr, B.A. 604-875-4111 ext 63196 firstname.lastname@example.org|
|Principal Investigator: Donna Hogge, M.D., Ph.D.|
|Winnipeg, Manitoba, Canada, R3M 1A5|
|Contact: Matthew Seftel, M.D. 204-787-2108 Matthew.Seftel@cancercare.mb.ca|
|Contact: Kathryn Dyck, B.A. 204-787-2127 Kathryn.Dyck@cancercare.mb.ca|
|Principal Investigator: Matthew Seftel, M.D.|
|Canada, Nova Scotia|
|Queen Elizabeth II Health Sciences Centre||Recruiting|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|Contact: Stephen Couban, M.D. 902-473-8562 Stephen.Couban@cdha.nshealth.ca|
|Contact: Susan Pleasance, BScN 902-473-7585 Susan.Pleasance@cdha.nshealth.ca|
|Principal Investigator: Stephen Couban, M.D.|
|Princess Margaret Cancer Centre (formerly Princess Margaret Hospital)||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Mark Minden, M.D. 416-946-4501 ext 5106 Mark.Minden@uhn.ca|
|Contact: Andrea Arruda, M.Sc. 416-946-4501 ext 2648 email@example.com|
|Principal Investigator: Mark Minden, M.D., Ph.D.|
|Montreal, Quebec, Canada, H1T 2M4|
|Contact: Julie Bergeron, M.D. 514-252-3404 firstname.lastname@example.org|
|Contact: Julie Lu, B.Sc. 514-254-7455 ext 3336 email@example.com|
|Principal Investigator: Julie Bergeron, M.D.|
|Principal Investigator:||Stephen Couban, M.D.||Capital District Health Authority, Canada|