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

May 30, 2016 updated by: Miguel Pera, Parc de Salut Mar

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients undergoing surgery for colon and rectal cancer with curative intent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non metastatic colon cancer patients
Consecutive patients undergoing elective surgery for non-metastatic colon or rectal cancer with curative intent.
Procedure: Surgery
Segmental resection for colon cancer and anterior resection in patients with rectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 5 years from the date of surgery
Time from the date of surgery to the date of first documentation of recurrence
5 years from the date of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-specific survival
Time Frame: 5 years from the date of surgery
Time from the date of surgery to death by colon cancer
5 years from the date of surgery
Local recurrence
Time Frame: 5 years from the date of surgery
Tumor associated with surgical site (anastomosis, tumor bed, and mesentery) and confirmed histologically or by imaging.
5 years from the date of surgery
Systemic recurrence
Time Frame: 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
5 years from the date of surgery
Postoperative intra-abdominal sepsis
Time Frame: 30 days from the date of surgery
Anastomotic leak or intra-abdominal abscess
30 days from the date of surgery
Postoperative mortality
Time Frame: 30 days from the date of surgery
30 days from the date of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Collaborators

University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

May 30, 2016

First Submitted That Met QC Criteria

May 30, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

May 30, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI15/00458

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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