- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02537990
MDS-CAN: A Prospective National MDS Clinical Database and Local Tissue Bank (MDS)
Study Overview
Status
Conditions
Detailed Description
o Participants will be seen and assessed for the study every 6 (+/-1) months. Follow-up for routine clinical care will be dictated by the physician. Clinical information relevant to the MDS diagnosis is entered such as IPSS, IPSS-R, treatments received and responses. Transfusion dependence is recorded. Relevant laboratories such as ferritin, LDH, CBC etc are entered q 6 months. Hospitalizations, bleeding and infections are recorded.
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Rena Buckstein, MD FRCPC
- Phone Number: 5847 416 480 6100
- Email: rena.buckstein@sunnybrook.ca
Study Contact Backup
- Name: Martha Lenis, BHA
- Phone Number: 85469 416 480 6100
- Email: martha.lenis@sunnybrook.ca
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4N3M5
- Recruiting
- Odette Cancer Center
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Contact:
- Rena J Buckstein, MD FRCPC
- Phone Number: 416-480-5847
- Email: rena.buckstein@sunnybrook.ca
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Contact:
- Richard Wells, MD FRCPC PhD
- Phone Number: 7928 416-480-6100
- Email: rwells@sri.utoronto.ca
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Sub-Investigator:
- Richard Wells, MD FRCPC PhD
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Sub-Investigator:
- Matthew Cheung, MD FRCPC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- New diagnosis of a Myelodysplastic syndrome
- 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:
- Patients whose diagnostic bone marrow exceed 2 years prior signing consent
- Subjects with AML and bone marrow blast of 31% or more at the time of signing consent
- Prior allogenic cell transplant
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
quality of life
Time Frame: every 6 months up to 6 years
|
every 6 months up to 6 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Rena Buckstein, MD FRCPC, Sunnybrook Health Science Centre
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDS Database
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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