Clinical trial NCT06507800: Cancer as a complicATion in reCipients of Autologous Hematopoietic Stem Cell Transplantation for Autoimmune Disease iNdiCation trEated in FRance and Canada?
Official title: Cancer as a complicATion in reCipients of Autologous Hematopoietic Stem Cell Transplantation for Autoimmune Disease iNdiCation trEated in FRance and Canada?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autoimmune Diseases
Keywords: Autoimmune diseases
Hematopoietic Stem Cell Transplantation
Cancer
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients treated bu AHSCT for their autoimmune disease, and followed either in France (MATHEC registry), Calgary (Canada) or Ottawa (Canada)

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.


Eligibility criteria: Inclusion Criteria:

1. Aged ≥ 18 years at AHSCT
2. Underwent first AHSCT for any AD indication
3. Included in the French MATHEC-SFGM-TC registry or the Canadian Ottawa and Calgary databases
4. AHSCT between January, 1st, 2000 and December, 31st, 2022
5. Informed consent for data registration in the respective original registry/database

Exclusion Criteria:

None

Primary outcomes:
measure: Cumulative incidence of any cancer after AHSCT for an autoimmune indication
timeFrame: Up to 22 years after AHSCT
Secondary outcomes:
measure: Cumulative incidence of cancer by age and sex
timeFrame: Up to 22 years after AHSCT
measure: Incidence of Non-relapse mortality (NRM)
timeFrame: Up to 22 years after AHSCT
measure: Incidence of disease relapse/progression
timeFrame: Up to 22 years after AHSCT
measure: Overall survival (OS)
timeFrame: Up to 22 years after AHSCT
measure: Causes of death (Causes of death will be classified as related to primary AD disease, the secondary cancer or any other cause).
timeFrame: Up to 22 years after AHSCT
Other outcomes:
Locations:
Study officials:
References: