Patient-Reported AutoImmunity Secondary to Cancer immunothErapy
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 905
- 试验地点
- 1
- 主要终点
- incidence of severe autoimmune manifestations in patients treated with BMS checkpoint inhibitors.
研究概览
简要总结
This is a real life observational longitudinal study aiming to identify autoimmune manifestations in patients treated with "checkpoint inhibitors" in mono or combo therapy in real life.
The study is based on patients reported experience validated by physician, recruited in cancer centers in France with another data collection from a French healthcare data claims database and a biological collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (over 18 year old) in France (DOM/TOM included), starting a monoclonal anti-PD-1 and/or anti-CTLA-4 immunotherapy for a cancer, whatever the cancer, within the Marketing Authorization.
- •As this research will be funded by BMS, for the e-Cohort, we will consider only patients treated by a BMS monoclonal antibody, to date: Ipilimumab (YERVOY©), Nivolumab (OPDIVO©) and Combo according to SmPCs.
- •All patients (anonymous) with a reimbursed checkpoint inhibitor drug in SNDS will be included for the healthcare database claims study.
- •Included patients should be able to understand and fill in questionnaires in French and should give informed consent and contact details, they should be able to read and answer emails in French.
- •French Healthcare insurance beneficiary, whatever the scheme is.
排除标准
- •Patients in all interventional clinical trials, with exclusion from other studies specifically mentioned
- •Patients deprived of liberty or guardianship
- •Women of childbearing potential with a desire of becoming pregnant
- •Major patients under tutorship.
- •Patients with dementia or drug addiction
- •Patients with no regular access to internet and phone
结局指标
主要结局
incidence of severe autoimmune manifestations in patients treated with BMS checkpoint inhibitors.
时间窗: 2 years after inclusion
Severe autoimmune manifestations is defined by : * Discontinuation (temporary or definitive) of the cancer immunotherapy related to Autoimmunity * or requirement for treatment due to auto-immune manifestations according to expert judgement * or hospitalization for autoimmune manifestations * or death related to autoimmune manifestations
次要结局
- Changes in patients' quality of life over time and the impacts of OASI(2 years after inclusion)
- Comparison of the age for the two groups of patients(2 years after inclusion)
- Comparison of the body-mass index for the two groups of patients(2 years after inclusion)
- Comparison of the gender for the two groups of patients(2 years after inclusion)
- Comparison of the types of cancer for the two groups of patients(2 years after inclusion)
- Comparison of the number of previous lines of chemotherapy for the two groups of patients(2 years after inclusion)
- Comparison of baseline predictive factors of autoimmune manifestations for the two groups of patients(2 years after inclusion)
- Event-free survival of patients(2 years after inclusion)
- Description of flares or worsening of pre-existing autoimmune diseases(2 years after inclusion)