Severe Aplastic Anaemia Working Party (SAAWP)
Study type:
Study number:
8409075
Type of treatment:
- None -
Diseases:
Bone marrow failure
Short title:
Androgens in bone marrow failure disorders
Primary objective:
To evaluate the use of androgens in BMF disorders in EBMT centers
Key inclusion criteria:
1) Diagnosis with an inherited or acquired BMF between 2000 and 2019;
2) Androgen-based treatment along patient's disease course, before or in the absence of allogeneic HSCT;
3) Patients of all ages.
Exclusion criterium: All patients receiving a transplant before androgen’s use do not qualify for this study.
2) Androgen-based treatment along patient's disease course, before or in the absence of allogeneic HSCT;
3) Patients of all ages.
Exclusion criterium: All patients receiving a transplant before androgen’s use do not qualify for this study.
Country:
All EBMT member countries
Principal investigator:
Simona Pagliuca, Austin Kulasekararaj
EBMT Study coordinator:
Brian Piepenbroek
Study coordinator email:
saawpebmt@lumc.nl
EBMT Study Unit:
Leiden Study Unit
Reason for processing personal data:
Patients’ data is needed to be able to identify the patient and calculate age at any time (impact on SAEs and response to clinical medications). Health care personal data is part of the CV collected for evidence of proper qualification for running the trial.
Categories of personal data collected:
DOB/YOB, gender
Medical data already reported to the EBMT Registry
Study Specific Questionnaire (MED-C)
Recipients who may access the data:
Leiden Study Unit
Statistical Unit
Investigators
3rd-party processors of Personal Data on behalf of EBMT/Service provider:
No
Privacy notices
Article 6 lawful basis for processing personal data:
Article 6.1 (a) - Consent (Collection)
Article 9 basis for processing special category data:
Article 9(2) (a) - Consent (Collection)
Is a Data Protection Impact Assessment required?:
DPIA performed for EBMT Registry (WP & NIS Studies)
Retention Schedule (if possible):
at least 5 years after the final report or first publication of study results