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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
Sponsor:
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
Information provided by (Responsible Party):
Dr. Rena Buckstein, Sunnybrook Health Sciences Centre

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.

Condition or disease
Myelodysplastic Syndrome (MDS)

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. quality of life [ Time Frame: every 6 months up to 6 years ]

Biospecimen Retention:   Samples With DNA
Specimens of bone marrow will be collected by aspiration when bone marrows are done for clinical purposes only. BM Plasma will be stored in aliquots, Mononuclear cells (MCs) will be isolated by density gradient centrifugation of buffy coat cells. The remainder of MC collected in this way will be used for immediate extraction of DNA by standard techniques.


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic, referrals from community physicians.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Rena Buckstein, MD FRCPC 416 480 6100 ext 5847 rena.buckstein@sunnybrook.ca
Contact: Martha Lenis, BHA 416 480 6100 ext 85469 martha.lenis@sunnybrook.ca

Locations
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Canada, Ontario
Odette Cancer Center Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Rena J Buckstein, MD FRCPC    416-480-5847    rena.buckstein@sunnybrook.ca   
Contact: Richard Wells, MD FRCPC PhD    416-480-6100 ext 7928    rwells@sri.utoronto.ca   
Sub-Investigator: Richard Wells, MD FRCPC PhD         
Sub-Investigator: Matthew Cheung, MD FRCPC         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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
Investigators
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Study Director: Rena Buckstein, MD FRCPC Sunnybrook Health Science Centre
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Rena Buckstein, Head Hematology Site Group, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02537990    
Other Study ID Numbers: MDS Database
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms