MDS-CAN: A Prospective National MDS Clinical Database and Local Tissue Bank (MDS)
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|ClinicalTrials.gov Identifier: NCT02537990|
Recruitment Status : Unknown
Verified November 2016 by Dr. Rena Buckstein, Sunnybrook Health Sciences Centre.
Recruitment status was: Recruiting
First Posted : September 2, 2015
Last Update Posted : November 16, 2016
|Condition or disease|
|Myelodysplastic Syndrome (MDS)|
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 :||Observational [Patient Registry]|
|Estimated Enrollment :||1200 participants|
|Target Follow-Up Duration:||6 Years|
|Official Title:||MDS-CAN: A Prospective National MDS Clinical Database and Local Tissue Bank|
|Study Start Date :||August 2005|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
- quality of life [ Time Frame: every 6 months up to 6 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537990
|Contact: Rena Buckstein, MD FRCPC||416 480 6100 ext firstname.lastname@example.org|
|Contact: Martha Lenis, BHA||416 480 6100 ext email@example.com|
|Odette Cancer Center||Recruiting|
|Toronto, Ontario, Canada, M4N3M5|
|Contact: Rena J Buckstein, MD FRCPC 416-480-5847 firstname.lastname@example.org|
|Contact: Richard Wells, MD FRCPC PhD 416-480-6100 ext 7928 email@example.com|
|Sub-Investigator: Richard Wells, MD FRCPC PhD|
|Sub-Investigator: Matthew Cheung, MD FRCPC|
|Study Director:||Rena Buckstein, MD FRCPC||Sunnybrook Health Science Centre|