MDS-CAN: A Prospective National MDS Clinical Database and Local Tissue Bank
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 1,200
- Locations
- 1
- Primary Endpoint
- quality of life
Study Overview
Brief Summary
The purposes of this study are: 1. To identify and quantify the health utilities and quality of life experienced by patients who have been diagnosed with MDS and what are their predictors. 2. Measure the effects of patient related factors like frailty and comorbidity on quality of life and overall survival or toxicity to therapy. 3. Assess how quality of life changes over time and what are its predictors. This will be valuable information that may guide therapy, transfusion practices, etc., as MDS is a chronic, incurable disease that is often progressive.
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
quality of life
Time Frame: every 6 months up to 6 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Rena Buckstein
Head Hematology Site Group
Sunnybrook Health Sciences Centre