Exploratory Clinical Evaluation of Personalized Functional Profiling in GI Tumors: Predicting Drug Response in CRC and PDAC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- PFP platform's predictive performance
研究概览
简要总结
The ColoPan study evaluates the scientific validity, reproducibility, and predictive performance of the Personalised Functional Profiling (PFP) platform in colorectal cancer and pancreatic ductal adenocarcinoma patients. It combines genomic sequencing with in vitro functional drug testing using patient-derived spheroids/organoids.
详细描述
The ColoPan study aims to evaluate the scientific validity, reproducibility, and predictive performance of the Personalised Functional Profiling (PFP) platform in colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) patients. The approach combines genomic sequencing with in vitro functional drug testing using patient-derived spheroids/organoids (PDSOs). The study aims to generate robust evidence that could inform the design of future interventional trials and contribute to the broader goal of refining personalised oncology strategies. The current protocol focuses on the new enrolment of PDAC participants, while data generated from prospective enrolment or biospecimens collected under the ethically approved SOCS study will be used under a secondary use agreement. The study aims to assess the scientific validity and predictive performance of the PFP platform in precision oncology research for CRC and PDAC, determining whether drug sensitivity profiles correlate with actual patient outcomes. The study also explores the feasibility of implementing PFP workflows in research settings and their potential for future integration into clinical trial design.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Signed informed consent form
- •≥ 18 years of age
- •Willing and able to comply with the protocol for the duration of the study, including data and sample collection
- •Patient scheduled for surgery or biopsy (primary tumour or metastasis) PDAC
排除标准
- •Female patient, pregnant, planning a pregnancy or breastfeeding.
- •Known active Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
- •Patient unable to understand and provide informed consent and has no family member representing him/her.
- •Patients with any other life-threatening illness, significant organ dysfunction or any clinically relevant conditions that, according to the hospital physician, could compromise the patient's safety.
研究组 & 干预措施
PDAC
Participants are included while scheduled for biopsy or surgery of their cancer.
干预措施: Personalized Functional Profiling (Other)
CRC
Participants are included while scheduled for biopsy or surgery of their colorectal cancer.
干预措施: Personalized Functional Profiling (Other)
结局指标
主要结局
PFP platform's predictive performance
时间窗: 0-5 years
Degree of concordance between drug sensitivity profiles generated by the PFP platform and actual clinical responses observed in patients with CRC and PDAC treated with Standard of Care therapies.
次要结局
- Assessment of the exploratory value of PFP-derived functional profiles(0-5 years)
- Feasibility and Operational Evaluation of the PFP Platform(0-5 years)