Cancer as a complicATion in reCipients of Autologous Hematopoietic Stem Cell Transplantation for Autoimmune Disease iNdiCation trEated in FRance and Canada?

NCT06507800 | Not Yet Recruiting

• 1 other identifier: APHP231300
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autoimmune Diseases

Keywords

Autoimmune diseases; Hematopoietic Stem Cell Transplantation; Cancer

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of any cancer after AHSCT for an autoimmune indication

  Description of the cancers by site according to the International Classification of Diseases for Oncology, 3rd Edition

  Up to 22 years after AHSCT

Secondary Outcomes (5)

• Cumulative incidence of cancer by age and sex

  Up to 22 years after AHSCT

• Incidence of Non-relapse mortality (NRM)

  Up to 22 years after AHSCT

• Incidence of disease relapse/progression

  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

Study Arms (3)

MATHEC cohort

French national registry of patients treated by Autologous haematopoietic stem cell transplantation (AHSCT) for their autoimmune disease

Other: Observational cohort

Ottawa cohort

Patients treated by AHSCT for their autoimmune disease and followed in Ottawa Hospital

Other: Observational cohort

Calgary cohort

Patients treated by AHSCT for their autoimmune disease and followed in Calgary Hospital

Other: Observational cohort

Interventions

Observational cohort OTHER

Cancer incidence after AHSCT for an autoimmune indication.

Calgary cohort; MATHEC cohort; Ottawa cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Autoimmune Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Dominique Farge, MD PhD

CONTACT

142499768; dominique.farge-bancel@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07