NCT02537990

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

14.5 years

First QC Date

August 19, 2015

Last Update Submit

November 15, 2016

Conditions

Myelodysplastic Syndrome (MDS)

Outcome Measures

Primary Outcomes (1)

  • quality of life

    every 6 months up to 6 years

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic, referrals from community physicians.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odette Cancer Center

Toronto, Ontario, M4N3M5, Canada

RECRUITING

Related Publications (2)

  • 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.

    PMID: 36095125DERIVED

  • Buckstein 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.

    PMID: 26991631DERIVED

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.

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Rena Buckstein, MD FRCPC

    Sunnybrook Health Science Centre

    STUDY DIRECTOR

Central Study Contacts

Rena Buckstein, MD FRCPC

CONTACT

416 480 6100rena.buckstein@sunnybrook.ca

Martha Lenis, BHA

CONTACT

416 480 6100martha.lenis@sunnybrook.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Hematology Site Group

Study Record Dates

First Submitted

August 19, 2015

First Posted

September 2, 2015

Study Start

August 1, 2005

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

November 16, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

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.

Locations

CA(1)