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UnknownNCT02789709

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

Status
Unknown
Phase
Study type
Observational
Enrollment
130 (estimated)
Sponsor
Parc de Salut Mar · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESurgerySegmental resection for colon cancer and anterior resection in patients with rectal cancer

Timeline

Start date
2016-01-01
Primary completion
2018-12-01
Completion
2019-12-01
First posted
2016-06-03
Last updated
2016-06-03

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT02789709. Inclusion in this directory is not an endorsement.