Comparative Health Status and Quality of Life of Patients With Sickle Cell Disease (SCD) Who Underwent Matched-sibling Hematopoietic Stem Cell Transplantation Versus Non Transplanted SCD Case-control Patients - Trial NCT06351462
Access comprehensive clinical trial information for NCT06351462 through Pure Global AI's free database. This phase not specified trial is sponsored by Assistance Publique - Hôpitaux de Paris and is currently Not yet recruiting. The study focuses on Sickle Cell Disease. Target enrollment is 220 participants.
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Study Focus
Sponsor & Location
Assistance Publique - Hôpitaux de Paris
Timeline & Enrollment
N/A
May 01, 2024
May 01, 2027
Primary Outcome
Evaluation of quality of life assessed by SF36
Summary
The long term burden of morbidity and mortality in the natural history of sickle cell disease
 has not been compared up to date to the risks and mortality of a curative option like bone
 marrow transplantation in severe sickle-cell disease patients. Given this lack of data,
 primary-care Sickle Cell Disease (SCD) physicians and transplant physicians are prevented
 from a factual debate over the benefit/risk ratio for each patient and refining indications
 of transplant in patients. Therefore, the present study seeks to describe and compare the
 very long-term outcomes after either Human Leukocyte Antigen (HLA) -matched sibling
 transplantation (study arm) and non-transplant care for severe sickle cell disease SCA
 patients in order to yield robust comparative data regarding both arms.
 
 The main objective is to assess the benefit of Hematopoietic stem cell transplantation (HSCT)
 regarding quality of life compared to standard care after 10 years, in patients with severe
 Sickle Cell Disease (SCD).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06351462
Non-Device Trial