Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Number of patients treated by immunotherapy and registered in the database.
研究概览
简要总结
ImmuCCo-1905 is a monocentric interventional study on patients treated by immunotherapy, which consist in establishment of a prospective clinic-biologic database over 5 years, associated with a biobank. This database will allow carrying out works aiming at assessing immunotherapy in real life situation.
详细描述
The aim of this study is to establish a prospective clinic-biologic database of patients treated by immunotherapy. This database will allowed to carry out works (such as translational research) aiming at assessing immunotherapy in real life situation.
Other objectives of the study include:
- Describe overall survival, progression-free survival, response to immunotherapy (in particular hyper-progression, pseudo-progression) considering the first tumor assessment and the best response, prolonged response
- Identifying prognostic factors of overall survival, progression-free survival, hyper-progression, best response under immunotherapy
- Describe AEs (Adverse Events) potentially associated with immunotherapy, their kinetics of appearance, from the start of treatment and after the end of treatment in order to assess the risk of delayed appearance
- To identify factors associated with increased risk of severe adverse event (grade > 2 or leading to end of treatment) potentially related to immunotherapy, from the beginning of immunotherapy to 1 year after this start of the treatment, in patients who received at least 4 doses or who stopped the treatment earlier (before 4 doses) due to toxicity.
- Identifying delayed adverse events potentially related to immunotherapy, occurring between 90 days and 1 year after the treatment discontinuation, in patients who received at least 4 doses or who stopped the treatment earlier (before 4 doses) due to toxicity.
- To identify and describe rare toxicities
- To evaluate the association between co-medications and disease evolution
- To evaluate the association between co-medications and toxicities occurrence
Translational research objectives:
- To identify biomarkers that might be associated with tumor response and/or toxicity of immunotherapy from:
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
- •Age ≥ 18 years
- •Beginning a first immunotherapy by immune checkpoint inhibitor - anti-PD1 (Programmed cell Death protein-1), anti-PDL1 (Programmed cell Death protein-1 ligand), anti-CTLA4 (Cytotoxic T-Lymphocyte associated protein 4), as monotherapy or in combination, in the Centre Oscar Lambret (COL)
- •In neo-adjuvant, adjuvant, recurrence or metastatic situation
- •Suffering from solid tumor histologically documented
- •Signed written informed consent
- •Patient covered by the French " "Social Security" regime If the patient is already enrolled in clinical trial involving immunotherapy, the agreement of the sponsor of this new trial will be sought before his/her inclusion.
排除标准
- •Pregnant or breastfeeding women
- •Patient already treated by immunotherapy by immune checkpoint inhibitor
- •Person under guardianship
- •Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
研究组 & 干预措施
ImmuCCo Cohort
Blood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity.
Urine collection at initiation of immunotherapy.
干预措施: ImmuCCo Cohort (Other)
结局指标
主要结局
Number of patients treated by immunotherapy and registered in the database.
时间窗: 5 years
Number of patients treated by immunotherapy and registered in the database
次要结局
- Overall Survival(6 years)
- Co-medications(6 years)
- Progression-Free Survival(6 years)
- Tumor response(6 years)
- Toxicity of immunotherapy(6 years)