French Assessment of Minimal Residual Disease by Liquid Biopsies in Pancreatic Ductal Adenocarcinoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- 3-year Disease-free survival (DFS)
研究概览
简要总结
The overall objective of this GUIDE.MRD consortium is to confirm that ctDNA detected after curative intended treatment for PDAC is a marker of residual disease and for risk-of-recurrence, and applicable in clinical practice.
Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-of-recurrence.
Specifically, the investigators want to determine the association between disease-free survival (DFS) and ctDNA detection status after
- curative-intended surgery and
- adjuvant chemotherapy.
FRENCH.MRD.PDAC is the French study of the european GUIDE.MRD project
详细描述
PDAC is the most common subtype of pancreatic cancer. The main pillars of non-metastatic PDAC clinical management are (i) surgery and (ii) neoadjuvant treatment including chemotherapy, which can be followed by external radiotherapy in case of borderline/locally advanced tumors.
Adjuvant chemotherapy is standard-of-care and is given to most patients that tolerate it after the extensive surgical procedure. The sequence of perioperative chemotherapy (before, after, both) is currently a matter of debate.
Despite extensive surgical resection and chemotherapy, most patients relapse, and median overall survival in the group of patients that is treated with surgery and modern chemotherapy regimens is below 24 months.
Throughout the body, DNA is released from cells into the circulation. This DNA is collectively referred to as cell-free DNA (cfDNA). In a patient with a solid cancer such as PDAC, a fraction of the cfDNA found in the blood, originates from tumor cells, and is termed circulating tumor DNA (ctDNA).
At present, a multitude of different ctDNA tests are available, and a common standard is lacking. This study is part of the large, EU-funded GUIDE.MRD project that aims to develop international reference standards for ctDNA diagnostics and use the best, standardized tests in clinically meaningful scenarios, including postsurgery follow-up of patients with PDAC, colorectal cancer, and lung cancer.
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
- •Pancreatic ductal adenocarcinoma, according to the assessment of the MDT.
- •Age 18 years or older.
- •Scheduled for curative intent surgical resection.
排除标准
- •Hereditary pancreatic cancer.
- •Verified distant metastases.
- •Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits and/or otherwise considered by the Investigator to be unlikely to complete the study.
- •Other cancers (excluding prior pancreatic cancer or skin cancer other than melanoma) within 3 years from eligibility screening.
- •Pregnant or nursing woman, or in childbearing age and not willing to use contraception
- •Adult subject to a legal protection
- •Not covered by Health insurance
- •Patient unable to understand and sign written informed consent.
研究组 & 干预措施
Pancreatic Ductal Adenocarcinoma patients
Resectable PDAC patients
干预措施: Blood sample/Liquid Biopsy (Biological)
结局指标
主要结局
3-year Disease-free survival (DFS)
时间窗: 3 years after the end of inclusion
Disease-free survival was defined as the time between the date of the baseline blood sampling/inclusion and the date of the first event among or recurrence or death from any cause.
次要结局
- Overall survival(3 years after the end of inclusion)
- Specificity (Sp) of the ctDNA diagnostics(3 years after the end of inclusion)
- Positive predictive value of the ctDNA diagnostics(3 years after the end of inclusion)
- Time to clinical recurrence(3 years after the end of inclusion)
- Negative predictive value of the ctDNA diagnostics(3 years after the end of inclusion)
- Sensitivity (Se) of the ctDNA diagnostics(3 years after the end of inclusion)
- Are Under the Curve of the ctDNA diagnostics(3 years atfer the end of inclusion)
- Time to molecular recurrence(3 years after the end of inclusion)