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NCT Number: NCT06507800

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

None

Treatment and study plan

Observational Cohort

Other

Cancer incidence after AHSCT for an autoimmune indication.

Primary outcomes

  1. Cumulative incidence of any cancer after AHSCT for an autoimmune indication

    Time frame: Up to 22 years after AHSCT

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

Secondary outcomes

  1. Cumulative incidence of cancer by age and sex

    Time frame: Up to 22 years after AHSCT

  2. Incidence of Non-relapse mortality (NRM)

    Time frame: Up to 22 years after AHSCT

  3. Incidence of disease relapse/progression

    Time frame: Up to 22 years after AHSCT

  4. Overall survival (OS)

    Time frame: Up to 22 years after AHSCT

  5. Causes of death (Causes of death will be classified as related to primary AD disease, the secondary cancer or any other cause).

    Time frame: Up to 22 years after AHSCT

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique Farge, MD PhD

CONTACT

[email protected]

142499768 ext. +33

Jérôme Lambert, MD PhD

CONTACT

[email protected]

142499742 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: CATCH CANCER

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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