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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autoimmune Diseases
• Intervention / Treatment: Other: Observational cohort

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jérôme Lambert, MD PhD; Phone Number: +33 142499742; Email: jerome.lambert@u-paris.fr
• Study Contact Backup: Name: Dominique Farge, MD PhD; Phone Number: +33 142499768; Email: dominique.farge-bancel@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MATHEC cohort; French national registry of patients treated by Autologous haematopoietic stem cell transplantation (AHSCT) for their autoimmune disease	Other: Observational cohort; Cancer incidence after AHSCT for an autoimmune indication.
Ottawa cohort; Patients treated by AHSCT for their autoimmune disease and followed in Ottawa Hospital	Other: Observational cohort; Cancer incidence after AHSCT for an autoimmune indication.
Calgary cohort; Patients treated by AHSCT for their autoimmune disease and followed in Calgary Hospital	Other: Observational cohort; Cancer incidence after AHSCT for an autoimmune indication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Hematopoietic Stem Cell Transplantation; Autoimmune diseases
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: APHP231300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No