A Study to Collect Patients, Medical, and Biological Data From Patients Being Treated for Metastatic Colorectal Cancer With a Specific Genetic Mutation: BRAFV600E
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UNICANCER
- 入组人数
- 400
- 试验地点
- 88
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The study will be conducted in patients with metastatic colorectal cancer (mCRC) harboring a BRAFV600E mutation, to collect clinical data and biological samples to be used for research but also to gather real-world clinical data concerning the treatments and the survival outcomes in patients with this pathology.
详细描述
Despite substantial progress made in the first- and second line mCRC settings, there are still unmet clinical needs for patients harboring BRAFV600E mutations, especially those with microsatellite stability (MSS) / proficient mismatch repair (pMMR) tumor. The overall survival and access to different treatment in the real-life setting are unknown. Moreover, patient prognosis remains poor and therapeutic resistance to combinations with BRAF inhibitors, is at present, nearly universal. Therefore, it seems essential to prospectively collect clinical and biological data about this rare mCRC subtype. These data will allow us to improve knowledge and to identify clinical and biological factors that could drive therapeutic decisions, predict resistance to treatments, and that are prognostic for survival. In this context, we designed this large, prospective, cohort study to collect clinical data and biological samples to be used for research but also to gather real-world clinical data concerning the treatments and the survival outcomes in patients with BRAFV600E mCRC.
This collection of clinical and biological data (tumor tissue and blood samples) will allow us to identify predictive and prognostic biomarkers with several research work packages planned:
i. To evaluate the circulating tumor DNA (ctDNA) during the metastatic first-, second-, and third-line treatment to:
- Evaluate its positive and negative predictive value.
- Identify molecular alterations preceding and explaining clinical resistance during BRAF/EGFR inhibition therapy and immunotherapy.
ii. To evaluate BRAFV600E mCRC immune environment both at the tumor and blood level (immunomonitoring).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Men and women aged 18 years or older
- •Histologically confirmed BRAFV600E metastatic colorectal cancer (mCRC), chemotherapy-naive in the metastatic setting or having initiated a first line of chemotherapy in the metastatic setting (except encorafenib-cetuximab treatment)
- •Available tumor tissue sample obtained before inclusion with sufficient tissue left for biological studies. Patients with only fine-needle aspirations are not eligible.
- •Known MMR/microsatellite status (immunohistochemistry [IHC] and polymerase chain reaction [PCR]) (or under analysis)
- •Patients must have signed a written informed consent form prior to any trial specific procedures. If the patients are physically unable to give their written consent, a trusted person of their choice, not related to the investigator or the sponsor, can confirm in writing the patient's consent.
- •Patients must be willing and able to comply with the study procedures
- •The patient must be affiliated to a social security system or benefit of such a system.
排除标准
- •Patient with another cancer concomitantly with the mCRC requiring treatment or influencing the prognosis according to the medical staff.
- •Patients for whom the follow-up will not be assured by the investigator or its team.
- •Any condition that may jeopardize patient participation in the study as well as non-contraception for men and women with child-bearing potential, and pregnancy or breast feeding for women.
- •Persons deprived of their liberty or under protective custody or guardianship.
结局指标
主要结局
Overall Survival (OS)
时间窗: From date of first diagnosis of mCRC and the date of death, whatever the cause, up to 5 years
OS of patients with BRAFV600E mCRC in the real-life setting. The OS is defined as the time between the date of first diagnosis of mCRC and the date of death, whatever the cause. The patients alive at the time of analysis will be censored at the date of their last follow up.
次要结局
- ctDNA kinetics modeling outcome parameters(From date of first diagnosis of mCRC until the date of first disease progression, up to 5 years)
- Disease control rate(From baseline to first disease progression, up to 5 years)
- Progression-free survival(From baseline to first disease progression, up to 5 years)
- Correlation between predictive biomarkers and response to treatment(Throughout study completion, up to 5 years)
- Collection of prospective data about BRAFV600E mCRC(Throughout study completion, up to 5 years)
- Correlation between prognostic markers and overall survival(Throughout study completion, up to 5 years)
- Correlation between prognostic markers and progression-free survival(From date of first diagnosis of mCRC and date of first progression or death, up to 5 years)
- Objective response rate(From baseline to first disease progression, up to 5 years)