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Fertility in SAA patients after allo-HCT prepared with Total Body Irradiation 2Gy

Severe Aplastic Anaemia Working Party (SAAWP)
Study type:
Retrospective Studies
Study number:
84090098
Type of treatment:
Allogeneic
Diseases:
Bone marrow failure
Short title:
Fertility after HCT for AA
Primary objective:
Assess fertility in SAA females aged 18-40 allografted following FLU-CY TBI 2 Gy.
Key inclusion criteria:
Inclusion criteria :
- females aged 18-40 years
- diagnosis of acquired aplastic anemia
- allogeneic HCT between 1980 and 2020
- conditioning regimen: Cy 200 or FLU-CY or FLU-CY_TBI 2Gy
- stem cell source: PB and BM
- GvHD prophylaxis: ATG CSA MTX or CSA MTX
Country:
All EBMT member countries
Principal investigator:
Andrea Bagicalupo
EBMT Study coordinator:
Joe Tuffnell
Study coordinator email:
saawp@ebmt.org
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:
Medical data already reported to the EBMT Registry
Study Specific Questionnaire (MED-C)
Recipients who may access the data:
Leiden Study Unit
Statistical Unit
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)

Data Protection Impact Assessments

Rights available to individuals:
Access
Data portability
Rectification
Objection
Deletion
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