Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351462
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-02
Brief Title:
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
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRANSPLANTORN2
Brief 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 benefitrisk 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None