Long-term Psychological and Cognitive Evaluation of Children Treated With Allogeneic Hematopoietic Stem Cell Transplantation for Immunodeficiency
- Primary Immunodeficiencies
- ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrolment target
- 30
- Started
- 19 September 2026
- Main results due
- September 2028
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Ages 6 years to 8 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Patients who underwent allogeneic transplantation for a primary immunodeficiency at Necker Hospital, regardless of the genetic diagnosis, and at least 2 years post Allogeneic hematopoietic stem cell transplantation. * Chronological age at the time of evaluation between 6 years and 8 years 11 months. * Holders of parental authority and children or adolescents or adults' patients informed and consenting to participate in the study Exclusion Criteria: * Child transplanted for a condition other than the primary immunodeficiency or at a different center. * Presence of an associated acquired or genetic neurological condition, independent of the PID, likely to significantly impair cognitive development. * Severe uncorrected sensory impairment (auditory or visual) rendering the cognitive assessment uninterpretable. * Refusal to participate by the child or those with parental authority. * Child not fluent in French or not proficient enough in French to complete the cognitive tests and questionnaires. * Profound intellectual disability.
What this study is about
In the sponsor’s own words, from the registry.
Primary immunodeficiencies (PIDs) are a large group of genetic diseases of the immune system with highly variable clinical presentations. Allogeneic hematopoietic stem cell transplantation (HSCT) is one of the treatments offered to some patients with PIDs. It is a curative but particularly demanding treatment, potentially life-threatening, requiring several months of hospitalization, prolonged limitations in social interactions for the patient, and impacting the entire family unit. The short-term complications of HSCT are numerous and well-known. However, few studies describe the long-term psychological and cognitive complications of HSCT, particularly in the context of PIDs. The few published studies in children concern patients transplanted for hematological malignancies, a context very different from that of primary immunodeficiencies.
This study is a pilot research project focusing on the multidimensional assessment of the neurocognitive, psychological, and psychosocial functioning of children between 6 and 8 years old who have received allogeneic hematopoietic stem cell transplantation for primary immunodeficiency for at least 2 years. These stringent criteria aim to limit biases related to the diversity of ages at which care is provided.
Study sites(1)
Hôpital Necker-Enfants Malades
Paris, France
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07766304. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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