MDS-CAN: A Prospective National MDS Clinical Database and Local Tissue Bank
NCT ID: NCT02537990
Last Updated: 2016-11-16
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
1200 participants
OBSERVATIONAL
2005-08-31
2020-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Dates and causes of death are documented Dates of leukaemia transformation are documented. Patients undergoing allogeneic stem cell transplant are documented with date of transplant.
QOL is assessed every 6 months:
QOL instruments are QLQ-C30, QUALMS, EQ-5D and global fatigue scale
Disability, frailty, comorbidity and physical performance is recorded on a yearly basis Disability scale is the Lawton Brody SIADL scale Frailty is measured using the Rockwood clinical frailty scale The comorbidity elements necessary to calculate the Charlson comorbidity scale and the MDS-CI of Della Porta et al. are recorded Physical performance tests are grip strength, 10x stand sit test and the 4 meter walk test
Investigators will continue to enroll new patients throughout this study period of 6 years, but the plan (funding permitting) is to continue this registry indefinitely, with later questions to be addressed.
* Monitoring and auditing data are completed every quarter by a dedicated national registry project manager.
* Monthly data checks are completed to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
* Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment and data collection has been created and posted electronically in the database for all sites.
* Plan of 25% drop off from death has been assumed due to conversion to AML or non leukemia death and 5% from lost of follow up loss to follow up. This is with the purpose to address situations where variables are reported as missing, unavailable, "non-reported," uninterpreted, or considered missing because of data inconsistency or out-of-range.
* Participant's results will be summarized descriptively as a whole and by province. KM survival curves will be generated and compared using the log-rank test. Univariate and multivariate cox proportional hazard nodel of overall survival will be performed to detect significant association with baseline covariates and time-dependent covariates such as frailty, comorbidity and QOL scores using Statistical Analysis Software (SAS) PHREG procedure.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* New diagnosis of CMML-1/CMML-2 and MDS/MPN
* New diagnosis of low blast AML (blasts 20-30%) as defined by the WHO classification (Vardiman, 2002)
* Greater than 18 years of age at the time of diagnosis
* Able to read, write and speak English or French (non-English or French speaking patients may participate if appropriate translation is used)
* Able to consent.
Exclusion Criteria
* Subjects with AML and bone marrow blast of 31% or more at the time of signing consent
* Prior allogenic cell transplant
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tom Baker Cancer Centre
OTHER
CancerCare Manitoba
OTHER
The Ottawa Hospital
OTHER
Princess Margaret Hospital, Canada
OTHER
Jewish General Hospital
OTHER
Health Sciences Centre, Winnipeg, Manitoba
OTHER
British Columbia Cancer Agency
OTHER
Providence Health & Services
OTHER
Vancouver Coastal Health
OTHER_GOV
Juravinski Cancer Center
OTHER
Réseau de Santé Vitalité Health Network
OTHER
Royal Victoria Hospital, Canada
OTHER
Capital Health, Canada
OTHER
Saskatoon City Hospital
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Rena Buckstein
Head Hematology Site Group
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rena Buckstein, MD FRCPC
Role: STUDY_DIRECTOR
Sunnybrook Health Science Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Odette Cancer Center
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Rena J Buckstein, MD FRCPC
Role: primary
Richard Wells, MD FRCPC PhD
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Buckstein R, Chodirker L, Mozessohn L, Yee KWL, Geddes M, Zhu N, Shamy A, Leitch HA, Christou G, Banerji V, Brian L, Khalaf D, St-Hilaire E, Finn N, Nevill T, Keating MM, Storring J, Delage R, Parmentier A, Thambipillai A, Siddiqui M, Westcott C, Cameron C, Mamedov A, Spin P, Tang D. A natural history of lower-risk myelodysplastic syndromes with ring sideroblasts: an analysis of the MDS-CAN registry. Leuk Lymphoma. 2022 Dec;63(13):3165-3174. doi: 10.1080/10428194.2022.2109154. Epub 2022 Sep 12.
Buckstein R, Wells RA, Zhu N, Leitch HA, Nevill TJ, Yee KW, Leber B, Sabloff M, St Hilaire E, Kumar R, Geddes M, Shamy A, Storring J, Kew A, Elemary M, Levitt M, Lenis M, Mamedov A, Zhang L, Rockwood K, Alibhai SM. Patient-related factors independently impact overall survival in patients with myelodysplastic syndromes: an MDS-CAN prospective study. Br J Haematol. 2016 Jul;174(1):88-101. doi: 10.1111/bjh.14033. Epub 2016 Mar 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MDS Database
Identifier Type: -
Identifier Source: org_study_id