PROPHETIC - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10,000
- 试验地点
- 41
- 主要终点
- Measured biological features at baseline (pre-treatment) and after 1st dose administration (on-treatment) and during treatment (optional)
研究概览
简要总结
The PROPHETIC study is a prospective, multi-center, international clinical study aimed at developing an algorithm to predict patient outcomes. The study involves analyzing the proteomic profiles of patients undergoing therapy to assess the likelihood of clinical benefit from their prescribed treatment. Blood samples are collected prior to and during the treatment period and analyzed as part of the ongoing development of thealgorithm.
详细描述
The goal of this research study is to develop an algorithm that predicts the patient's treatment outcome.This algorithm will serve as a tool for physicians when making treatment decisions, specifically for stage IV NSCLC and malignant melanoma patients receiving anti-cancer treatments. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide two blood samples and clinical data will be collected from their medical records.
In the first part of the trial, the data obtained from the blood samples and the medical records of the patients will be used to develop the prediction algorithm, and in the second part of the trial, the algorithm will be validated by comparing the objective response rate of the patients to the theoretical response prediction of the algorithm.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- •Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug
- •Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
结局指标
主要结局
Measured biological features at baseline (pre-treatment) and after 1st dose administration (on-treatment) and during treatment (optional)
时间窗: Measured biological features are analyzed in samples taken at baseline (prior treatment) and after the 1st dose administration (on-treatment) and during treatment (optional)
Biological features are analyzed in biological samples taken from the patients as part of the study
Overall response as determined by RECIST 1.1 or any other validated clinical scales for response, every 3 months or according to the standard of care
时间窗: Every 3 months or according to the standard of care
Overall response as determined by RECIST 1.1 or any other validated clinical scales for response, every 3 months or according to the standard of care
Progression Free Survival (PFS)
时间窗: At progression during treatment
Collect Progression Free Survival (PFS) dates
Overall survival or last follow-up
时间窗: Overall survival or last follow-up
Collect overall survival or last follow-up dates
次要结局
- Adverse Events (AE)(Adverse events (AE) during treatment and until the end of study)