Metabolomic Phenotyping After Surgery for Colon Cancer: Study of Novel Predictive Biomarkers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
Predictive biomarkers are needed to identify those patients with higher risk of recurrence after surgery for colon cancer with curative intent. Our main objective is to determine a metabolite profile in blood plasma from patients operated from colorectal cancer that can be associated with the oncologic outcome and be validated as predictive biomarkers in future studies. A secondary objective is to study the glycolytic metabolism of colon cancer cell lines treated with plasma samples from the same patients. In particular, to validate the increased utilization of lactate by tumor cells as a metabolic substrate using postoperative human samples.
Patients with colorectal cancer that have undergone surgical resection will be included. Plasma samples will be obtained before surgery and the 4th day and the 3rd, 6th, 12th, and 18th months after surgery. Metabolic profiles in plasma samples will be determined using a kit that allows the quantification of 180 metabolites by mass spectrometry.
A clinical follow up will be maintained for at least 2 years to identify tumor recurrences.
详细描述
Up to 30-40% of patients operated from colorectal cancer display tumor recurrence. Predictive biomarkers are needed to identify those patients with higher risk of recurrence. Our main objective is to determine a metabolite profile in blood plasma from patients operated from colorectal cancer that can be associated with the oncologic outcome and be validated as prognostic biomarkers in future studies. A secondary objective is to study the glycolytic metabolism of colon cancer cell lines treated with plasma samples from the same patients. In particular, to validate the increased utilization of lactate by tumor cells as a metabolic substrate using postoperative human samples, as it was previously observed by us in vitro using an inflammatory environment in conditions of hypoxia and lack of glucose. Patients with colorectal cancer that have undergone surgical resection will be included. Plasma samples will be obtained before surgery and the 4th day and the 3rd, 6th, 12th, and 18th months after surgery. Metabolic profiles in plasma samples will be determined using a kit that allows the quantification of 180 metabolites by mass spectrometry. Cellular assays will be performed on the SW620 and HT-29 colon cancer cell lines. Cells will be treated with plasma samples and the concentration of lactate and other metabolites will be analyzed in the medium supernatants. A clinical follow up will be maintained for at least 2 years to identify tumor recurrences.
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
- •Non-metastatic colon and rectal cancer undergoing surgery with curative intent
- •Patients signed informed consent
排除标准
- •Patients undergoing preoperative chemotherapy and/or radiotherapy
- •Emergency surgery
- •Surgical resection R1 or R2
- •Patients presenting with other known malignancies for which they are receiving treatment
结局指标
主要结局
Disease-free survival
时间窗: 5 years from the date of surgery
Time from the date of surgery to the date of first documentation of recurrence
次要结局
- Postoperative mortality(30 days from the date of surgery)
- Disease-specific survival(5 years from the date of surgery)
- Systemic recurrence(5 years from the date of surgery)
- Postoperative intra-abdominal sepsis(30 days from the date of surgery)
- Local recurrence(5 years from the date of surgery)
研究者
Miguel Pera
MD
Parc de Salut Mar