The Prognostic Performance of Liquid Biopsy in Peritoneal Lavage and Plasma of Patients With Locally Advanced Gastric Cancer (LIQUID Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Prognostic impact of ctDNA positivity
研究概览
简要总结
This study investigates the prognostic role of liquid biopsy in patients with locally advanced gastric cancer.
Liquid biopsy for the detection of circulating tumor DNA will be performed:
- In the peritoneal lavage, during staging laparoscopy (if indicated) and during curative gastrectomy
- In plasma, before staging laparoscopy (if indicated), before curative gastrectomy, at hospital discharge, three months after surgery/at the end of adjuvant therapy, and in case of disease recurrence.
The aim of this study is to determine the predictive power of liquid biopsy on overall survival and disease free survival.
详细描述
The purpose of this prospective observational study is to determine the prognostic role of liquid biopsy for the detection of circulating tumor DNA (ctDNA) in patients with locally advanced gastric cancer.
Patients with cT3-4 and or N+ gastric cancer will proceed to either staging laparoscopy, if preoperative chemotherapy is indicated, or upfront radical surgery within 2 weeks from the last imaging assessment.
Liquid biopsy will be performed with peritoneal lavage and blood samples. Peritoneal lavage is performed with 500 ml of saline, starting from the retrogastric space (100 ml) and following clockwise from right upper quadrant to right lower using 100 ml for each quadrant. At the end of peritoneal lavage, 250 ml of saline solution is collected over the liver, after having positioned the patient in Trendelenburg position and on the right side. Of the collected fluid, 50 mL will be sent for cytological examination and 50 mL will be stocked for ctDNA analyses.
In case of upfront radical surgery, liquid biopsy will be performed at the following time points:
- Through blood samples performed before skin incision and 7-10 days after radical surgery;
- Through peritoneal lavage, immediately after laparotomy/laparoscopy.
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
- •Histologically proven gastric or gastro-esophageal junction (GEJ -Siewert type II -III) adenocarcinoma
- •More than cT2 and/or N + (UICC 8th edition)
- •Written informed consent
排除标准
- •Presence of ascites or distant metastases
- •Previous chemotherapy for gastric adenocarcinoma
- •Previous gastric surgery
- •Absolute contraindications to surgery
- •Concomitant malignancies or history of other malignancies in the previous 5 years (with exception of in situ cervical carcinoma, basal cell carcinoma, superficial bladder tumors are allowed if curatively treated).
结局指标
主要结局
Prognostic impact of ctDNA positivity
时间窗: At disease recurrence or at 3-year follow up
To evaluate the prognostic impact (overall survival and disease-free survival) of ctDNA positivity in peritoneal lavage and peripheral blood of patients with resectable, stage \< IV, gastric cancer
次要结局
- Correlation between ctDNA detection and clinical and tumoral patients' characteristics(Peritoneal lavage: at staging laparoscopy and at curative surgery; plasma: before staging laparoscopy, before curative surgery, at hospital discharge, 3 months after surgery/at the end of adjuvant therapy, at disease recurrence)
- Rate of ctDNA positivity in peritoneal lavage and peripheral blood(Peritoneal lavage: at staging laparoscopy and at curative surgery; plasma: before staging laparoscopy, before curative surgery, at hospital discharge, 3 months after surgery/at the end of adjuvant therapy, at disease recurrence)
- Prognostic impact of ctDNA positivity in peritoneal lavage and peripheral blood on the risk of peritoneal and distant metastases(Peritoneal lavage: at staging laparoscopy and at curative surgery; plasma: before staging laparoscopy, before curative surgery, at hospital discharge, 3 months after surgery/at the end of adjuvant therapy, at disease recurrence)
- Dynamics of ctDNA detection in peritoneal lavage and peripheral blood in patients undergoing pre-operative chemotherapy(Peritoneal lavage: at staging laparoscopy and at curative surgery; plasma: before staging laparoscopy, before curative surgery, at hospital discharge, 3 months after surgery/at the end of adjuvant therapy, at disease recurrence)
- Dynamics of ctDNA detection in peripheral blood in patients undergoing pre-and post-operative chemotherapy, and at disease recurrence(Peritoneal lavage: at staging laparoscopy and at curative surgery; plasma: before staging laparoscopy, before curative surgery, at hospital discharge, 3 months after surgery/at the end of adjuvant therapy, at disease recurrence)
研究者
Carlo Sposito
Staff Surgeon
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano