Circulating Tumor DNA as Surgical Biomarker in Patients With PancrEatic Adenocarcinoma for Statement of Resectability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Disease relapse
研究概览
简要总结
The main objective is the evaluation of the prognostic value of ctDNA (circulating tumor DNA) as a marker of surgical futility in patients with operable PDAC.
详细描述
In the era of personalized medicine and treatments guided by tumor biology, no specific tumor marker has real prognostic value. This is the reason why the search for a specific marker through a noninvasive blood test that can give indications on the usefulness of the resectability of pancreatic adenocarcinoma would be very valuable. Our project proposes the evaluation of ctDNA during various treatment courses of patients with PDAC in order to evaluate its efficacy as a prognostic and predictive marker of response to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients with PDAC with indication to surgical resection, including those undergoing upfront surgery or surgery following induction treatment. Non resectable patient defined as a patient with surgical indication at standard preoperative clinical, biological and morphological evaluation, but eventually not resected because of advanced disease or contraindications revealed during surgical exploration will be excluded
- •Non-metastatic status confirmed by an abdomen CT-scan (as our routine clinical practice).
- •Patients able to give a specific informed consent.
- •Age ≥ 18 years.
排除标准
- •Non resectable patient defined as a patient with surgical indication at standard preoperative clinical, biological and morphological evaluation, but eventually not resected because of advanced disease or contraindications revealed during surgical exploration will be excluded (drop-out)
- •Non-controlled congestive heart failure.
- •Non-treated angina.
- •Recent myocardial infarction (in the previous year).
- •Non-controlled AHT (SBP >160 mm or DBP > 100 mm, despite optimal drug treatment).
- •Major non-controlled infection.
- •Severe liver failure.
- •Age < 18 years.
- •Informed consent not signed.
- •Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception.
结局指标
主要结局
Disease relapse
时间窗: 2 years
disease relapse at 2 years after surgery
次要结局
未报告次要终点