Recruiting

Observational Study

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT02537990

Conditions

Myelodysplastic Syndrome (MDS)

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Myelodysplastic Syndrome (MDS)

Study ID

NCT02537990

Start date

Aug, 2005

Status verified date

Nov, 2016

Completion date

Feb, 2020

Anticipated

Primary completion date

Feb, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • quality of life [ Time Frame: every 6 months up to 6 years ]

Central Contacts and Locations

Central contacts

Rena Buckstein, MD FRCPC

416 480 6100rena.buckstein@sunnybrook.ca

Martha Lenis, BHA

416 480 6100martha.lenis@sunnybrook.ca

Locations

Odette Cancer Center

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Rena J Buckstein, MD FRCPC

416-480-5847rena.buckstein@sunnybrook.ca

Richard Wells, MD FRCPC PhD

416-480-6100rwells@sri.utoronto.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Nov 16, 2016

Last verified

Nov, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2016-11-16.