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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04819607




Registration number
NCT04819607
Ethics application status
Date submitted
24/03/2021
Date registered
29/03/2021
Date last updated
23/08/2021

Titles & IDs
Public title
The Evaluating Multidisciplinary Bone Marrow Failure Care in Bone Marrow Failure and Related Disorders.
Scientific title
The Evaluating Multidisciplinary Bone Marrow Failure Care in Bone Marrow Failure and Related Disorders.(The EMBRACE Study)
Secondary ID [1] 0 0
21/44
Universal Trial Number (UTN)
Trial acronym
EMBRACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Marrow Failure Syndrome 0 0
Aplastic Anemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia
Blood 0 0 0 0
Haematological diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - model of care

BMFS patients - Patients with BMFS attending Peter MacCallum Cancer Centre haematology clinic.


Other interventions: model of care
Multidisciplinary model of care for BMFS patients.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
to assess the effectiveness and implementation of the model of care through a mixture of objective metrics and patient /physician reported outcomes
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
To assess longitudinal quality of life assessment in patients being treated with the model
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
To quantitate healthcare usage of patients within the model
Timepoint [2] 0 0
12 months

Eligibility
Key inclusion criteria
Patients must meet all the following criteria for study entry:

1. Age > or = 18 years at enrolment

2. Able to give informed consent (or responsible family member able to give informed
consent)

3. Patient is receiving care under the institutional guidelines/stream model of care
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient not eligible for management under the model of care

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a prospective hybrid implementation-effectiveness study of a model of care for
patients with bone marrow failure syndromes and inherited predisposition to haematological
malignancy that includes comprehensive diagnostic genomic evaluation, multidisciplinary case
review, provision of clinical care including from clinical haematologists, medical
geneticists and genetic counsellors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04819607
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Piers Blombery, MBBS(Hons)
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mary Panjari, PhD
Address 0 0
Country 0 0
Phone 0 0
03 8559 5000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04819607