Metabolomic Phenotyping After Surgery for Colon Cancer: Study of Novel Predictive Biomarkers

• Conditions: Colon Cancer
• Interventions: Procedure: Surgery

• Registration Number: NCT02789709
• Lead Sponsor: Parc de Salut Mar

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-05
• Study First Submitted: 2016-05-30
• Study First Submitted QC: 2016-05-30
• Last Update Submitted: 2016-05-30
• Study First Posted: 2016-06-03
• Last Update Posted: 2016-06-03
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Non-metastatic colon and rectal cancer undergoing surgery with curative intent
• Patients signed informed consent

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non metastatic colon cancer patients	Surgery	Consecutive patients undergoing elective surgery for non-metastatic colon or rectal cancer with curative intent.

Primary Outcome Measures

Name	Time	Method
Disease-free survival	5 years from the date of surgery	Time from the date of surgery to the date of first documentation of recurrence

Secondary Outcome Measures

Name	Time	Method
Postoperative mortality	30 days from the date of surgery
Disease-specific survival	5 years from the date of surgery	Time from the date of surgery to death by colon cancer
Systemic recurrence	5 years from the date of surgery	Spread of the disease outside the surgical field to organs such as the liver, lungs, bones, or brain
Postoperative intra-abdominal sepsis	30 days from the date of surgery	Anastomotic leak or intra-abdominal abscess
Local recurrence	5 years from the date of surgery	Tumor associated with surgical site (anastomosis, tumor bed, and mesentery) and confirmed histologically or by imaging.

Trial Locations

Locations (1)

Hospital del Mar Medical Research Institute; 🇪🇸 Barcelona, Spain