Paediatric Diseases Working Party (PDWP)
Study type:
Study number:
8417036
Type of treatment:
Allogeneic
Diseases:
Bone marrow failure
Short title:
CAMT study
Primary objective:
Primary Aim: The aim is to evaluate outcomes of paediatric patients with congenial amegakaryocytic thrombocytopenia.
Key inclusion criteria:
• Age at TX < 18years
• First allogeneic transplant
• Diagnosis: Congenial amegakaryocytic thrombocytopenia
• Year of inclusion: Until 2019 (included
• First allogeneic transplant
• Diagnosis: Congenial amegakaryocytic thrombocytopenia
• Year of inclusion: Until 2019 (included
Country:
All EBMT member countries
Principal investigator:
Clémence Aldebert
EBMT Study coordinator:
Arnaud Dalissier
Study coordinator email:
arnaud.dalissier@upmc.fr
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.
Research and Development of new and improved transplant, cell therapy and immunosuppression procedures.
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:
Paris Study 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)
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