MDS-CAN: A Prospective National MDS Clinical Database and Local Tissue Bank

Myelodysplastic Syndrome (MDS) Clinical Trial

— MDS  

Official title:

MDS-CAN: A Prospective National MDS Clinical Database and Local Tissue Bank

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02537990
• Other study ID #: MDS Database
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2015
• Last updated: November 15, 2016
• Start date: August 2005
• Est. completion date: February 2020

Study information

• Verified date: November 2016
• Source: Sunnybrook Health Sciences Centre
• Contact: Rena Buckstein, MD FRCPC
• Phone: 416 480 6100
• Email: rena.buckstein[@]sunnybrook.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Preleukemia

Locations

Country	Name	City	State
Canada	Odette Cancer Center	Toronto	Ontario

Sponsors (15)

Lead Sponsor

Collaborator

Sunnybrook Health Sciences Centre

British Columbia Cancer Agency, CancerCare Manitoba, Capital Health, Canada, Health Sciences Centre, Winnipeg, Manitoba, Jewish General Hospital, Juravinski Cancer Center, Princess Margaret Hospital, Canada, Providence Health & Services, Réseau de Santé Vitalité Health Network, Royal Victoria Hospital, Canada, Saskatoon City Hospital, The Ottawa Hospital, Tom Baker Cancer Centre, Vancouver Coastal Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life		every 6 months up to 6 years	No