Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507800
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Cancer as a complicATion in reCipients of Autologous Hematopoietic Stem Cell Transplantation for Autoimmune Disease iNdiCation trEated in FRance and Canada
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cancer as a complicATion in reCipients of Autologous Hematopoietic Stem Cell Transplantation for Autoimmune Disease iNdiCation trEated in FRance and Canada
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CATCH CANCER
Brief Summary:
Autologous Hematopoietic Stem Cell Transplantation AHSCT is a treatment option for several types of Autoimmune Disease AD in patients who remain active despite disease modifying therapies In this setting AHSCT was shown to improve overall survival event free survival and quality of life with a grade A level evidence for systemic sclerosis SSc and multiple sclerosis MS patients and its benefit varies according to the AD type and the patient status for the other indications The number of AHSCT for AD has increased in the past twenty years at each country level in Europe and also in Canada
Information about cancer after AHSCT for AD is scant although the AD patients population per se has an increased rate of cancer This cancer risk can be explained in part by the long term use of immunosuppressive drugs or by other risk factors related to the AD as in SSc or Crohn or to the patient In addition to pretransplant potential risk factors for cancer in AD patients the use of conditioning regimen which may vary from low medium or high immunosuppressive to myeloablative chemotherapy when irradiation is added to the proecedure may favor the onset of cancer after AHCST Updated analysis and review of the literature until march 2023 led us to identify only twenty-two cases of cancer or hematological malignancies reported after AHSCT recipients for an AD
The incidence of cancer after AHSCT for AD was never considered as a primary endpoint in any previous study
In this context the aim of this study is to describe the incidence of cancer after autologous hematopoietic stem cell transplantation AHSCT for auto-immune diseases AD in the French MATHEC French scientific network for AD and cellular therapies and the Ottawa and Calgary patients cohorts from Day 0 until twenty years follow up after AHSCT
Information about cancer after AHSCT for AD is scant although the AD patients population per se has an increased rate of cancer This cancer risk can be explained in part by the long term use of immunosuppressive drugs or by other risk factors related to the AD as in SSc or Crohn or to the patient In addition to pretransplant potential risk factors for cancer in AD patients the use of conditioning regimen which may vary from low medium or high immunosuppressive to myeloablative chemotherapy when irradiation is added to the proecedure may favor the onset of cancer after AHCST Updated analysis and review of the literature until march 2023 led us to identify only twenty-two cases of cancer or hematological malignancies reported after AHSCT recipients for an AD
The incidence of cancer after AHSCT for AD was never considered as a primary endpoint in any previous study
In this context the aim of this study is to describe the incidence of cancer after autologous hematopoietic stem cell transplantation AHSCT for auto-immune diseases AD in the French MATHEC French scientific network for AD and cellular therapies and the Ottawa and Calgary patients cohorts from Day 0 until twenty years follow up after AHSCT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None