跳至主要内容
临床试验/NCT06507800
NCT06507800尚未招募不适用

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

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 500 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
主要终点
Cumulative incidence of any cancer after AHSCT for an autoimmune indication

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Cumulative incidence of any cancer after AHSCT for an autoimmune indication

时间窗: Up to 22 years after AHSCT

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

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