Cancer as a complicATion in reCipients of Autologous Hematopoietic Stem Cell Transplantation for Autoimmune Disease iNdiCation trEated in FRance and Canada?
- Conditions
- Autoimmune Diseases
- Interventions
- Other: Observational cohort
- Registration Number
- NCT06507800
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Aged ≥ 18 years at AHSCT
- Underwent first AHSCT for any AD indication
- Included in the French MATHEC-SFGM-TC registry or the Canadian Ottawa and Calgary databases
- AHSCT between January, 1st, 2000 and December, 31st, 2022
- Informed consent for data registration in the respective original registry/database
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MATHEC cohort Observational cohort French national registry of patients treated by Autologous haematopoietic stem cell transplantation (AHSCT) for their autoimmune disease Ottawa cohort Observational cohort Patients treated by AHSCT for their autoimmune disease and followed in Ottawa Hospital Calgary cohort Observational cohort Patients treated by AHSCT for their autoimmune disease and followed in Calgary Hospital
- Primary Outcome Measures
Name Time Method Cumulative incidence of any cancer after AHSCT for an autoimmune indication Up to 22 years after AHSCT Description of the cancers by site according to the International Classification of Diseases for Oncology, 3rd Edition
- Secondary Outcome Measures
Name Time Method Incidence of Non-relapse mortality (NRM) Up to 22 years after AHSCT Cumulative incidence of cancer by age and sex Up to 22 years after AHSCT Overall survival (OS) Up to 22 years after AHSCT Causes of death (Causes of death will be classified as related to primary AD disease, the secondary cancer or any other cause). Up to 22 years after AHSCT Incidence of disease relapse/progression Up to 22 years after AHSCT