Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- efficacy of treatment against Cancer
研究概览
简要总结
The purpose of this study is to collect blood samples, as well as tumor tissue for genetic analysis. The collection of samples will allow the creation of a plasma bank. Targeted individuals are cancer patients of all types, treated with immunotherapy or targeted therapy.
Immunotherapy or targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.
With the aim to identify predictive markers of response to treatment or possible resistance mechanism, the plasma samples and the tumor samples will be used for genetic analysis, for example but not limited to, whole exome sequencing. This may lead to the discovery of some germinal mutations implicated in other diseases than cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking and allocation tbc
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
- •Patients with cancer treated with one of the following regimens: Molecular targeted agents or Immunotherapy
- •Paraffin-embedded tumor tissue available for immunohistochemistry and/or DNA extraction.
- •Patient able to give written informed consent.
排除标准
- •Patients with cancer treated with other regimen
研究组 & 干预措施
MOLECULAR TARGETED THERAPIES
Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.
干预措施: Molecular Target (Drug)
IMMUNOTHERAPY
Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.
干预措施: Immunotherapeutic Agent (Drug)
结局指标
主要结局
efficacy of treatment against Cancer
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Efficacy will be determined in terms of overall responses according to standard practice by the local investigator. Disease and response assessments are defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
次要结局
- Overall survival (OS)(From date of randomization until the date of first documented progression assessed up to 120 months)
- Progression free survival(From date of randomization until the date of first documented progression , assessed up to 120 months)
- Objective tumor response(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months)