ong-term integrity of hematopoiesis in pediatric stem cell transplantation survivors
Recruiting
- Conditions
- Hematopoietic stem cell transplantationbone marrow transplantation1000208610027665
- Registration Number
- NL-OMON54142
- Lead Sponsor
- Prinses Máxima Centrum voor Kinderoncologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 375
Inclusion Criteria
Underwent allogeneic HSCT at age <40 yrs
A minimum survival of 5 years after HSCT.
Exclusion Criteria
Failure of the HSCT recipient, donor and/or their legal representatives to
understand the patient information and informed consent form (either due to
intellectual disability or to language problems).
Recipients of a *NiCord* HSCT. NiCord is a clinical trial on the safety and
efficacy of transplantation of ex vivo expanded cord blood HSCs. As outcome
measures of our study overlap with the outcome of this trial, NiCord recipients
will be excluded.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary aim of this study is to determine the percentage of long-term HSCT<br /><br>survivors with clonal hematopoiesis (CH), and to identify clinical determinants<br /><br>that are associated with CH. </p><br>
- Secondary Outcome Measures
Name Time Method <p>We also aim to determine the percentage of long-term HSCT survivors with the<br /><br>following other types of hematopoietic dysfunction: (1) cytopenia; (2) loss of<br /><br>donor chimerism; (3) bone marrow failure; (4) myelodysplasia; and (5)<br /><br>donor-cell leukemia. Finally, we will perform in-depth molecular studies to<br /><br>analyze hematopoietic integrity upon HSCT, including genomic and flow<br /><br>cytometric analyses. </p><br>