Myelodysplastic Syndrome (MDS)MDSNCT02537990
MDS-CAN: A Prospective National MDS Clinical Database and Local Tissue Bank
An observational study of Myelodysplastic Syndrome (MDS), run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Myelodysplastic Syndrome (MDS)
- How many people
- 1,200 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2005to Feb 2020
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic, referrals from community physicians.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Odette Cancer Center
Toronto, Ontario, M4N3M5
Rena J Buckstein, MD FRCPC, 416-480-5847, rena.buckstein@sunnybrook.ca
Richard Wells, MD FRCPC PhD, 416-480-6100 ext. 7928, rwells@sri.utoronto.ca
About this study
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.
Read the detailed description
- 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.
- Conditions
- Myelodysplastic Syndrome (MDS)
- Medical subject headings
- Myelodysplastic Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
Measured: every 6 months up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startAug 2005
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic Syndrome (MDS)Studies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Tom Baker Cancer Centre, CancerCare Manitoba, The Ottawa Hospital, Princess Margaret Hospital, Canada, Jewish General Hospital, Health Sciences Centre, Winnipeg, Manitoba, British Columbia Cancer Agency, Providence Health & Services, Vancouver Coastal Health, Juravinski Cancer Center, Réseau de Santé Vitalité Health Network, Royal Victoria Hospital, Canada, Capital Health, Canada, Saskatoon City Hospital
- Responsible party
- Principal investigator, Dr. Rena Buckstein, Sunnybrook Health Sciences Centre
- Investigators
- Rena Buckstein, MD FRCPC, Study director, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537990
- Sponsor's protocol ID
- MDS Database
- Acronym
- MDS
- Status last verified
- Nov 2016
- First submitted
- 19 Aug 2015
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Individual participant data can be available to other researchers for their own patients from that center but not other centers. Collective anonymized data of all registry patients is available to them however.
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.
PubMed 36095125Buckstein 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.
PubMed 26991631
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MDS-CAN: A Prospective National MDS Clinical Database and Local Tissue Bank
- ClinicalTrials.gov ID
- NCT02537990
- Acronym / sponsor ID
- MDS / MDS Database
- Conditions
- Myelodysplastic Syndrome (MDS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Tom Baker Cancer Centre, CancerCare Manitoba, The Ottawa Hospital, Princess Margaret Hospital, Canada, Jewish General Hospital, Health Sciences Centre, Winnipeg, Manitoba, British Columbia Cancer Agency, Providence Health & Services, Vancouver Coastal Health, Juravinski Cancer Center, Réseau de Santé Vitalité Health Network, Royal Victoria Hospital, Canada, Capital Health, Canada, Saskatoon City Hospital
- Study start
- Aug 2005
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic, referrals from community physicians.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
quality of life
Time frame: every 6 months up to 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Derived from this study: PubMed 36095125Buckstein 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.
- Derived from this study: PubMed 26991631Buckstein 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.
- Individual participant dataSharing planned: Yes. Individual participant data can be available to other researchers for their own patients from that center but not other centers. Collective anonymized data of all registry patients is available to them however.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rena Buckstein, MD FRCPC study director
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndrome (MDS), run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rena Buckstein, MD FRCPC (416 480 6100 ext. 5847, rena.buckstein@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life (time frame: every 6 months up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02537990, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016; AzTrials last refreshed its copy on 6 Nov 2026.