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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02789709
Enrollment
130
Registered
2016-06-03
Start date
2016-01-31
Completion date
2019-12-31
Last updated
2016-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

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.

Interventions

PROCEDURESurgery

Segmental resection for colon cancer and anterior resection in patients with rectal cancer

Sponsors

University of Barcelona
CollaboratorOTHER
Parc de Salut Mar
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Disease-free survival5 years from the date of surgeryTime from the date of surgery to the date of first documentation of recurrence

Secondary

MeasureTime frameDescription
Postoperative mortality30 days from the date of surgery
Local recurrence5 years from the date of surgeryTumor associated with surgical site (anastomosis, tumor bed, and mesentery) and confirmed histologically or by imaging.
Systemic recurrence5 years from the date of surgerySpread of the disease outside the surgical field to organs such as the liver, lungs, bones, or brain
Postoperative intra-abdominal sepsis30 days from the date of surgeryAnastomotic leak or intra-abdominal abscess
Disease-specific survival5 years from the date of surgeryTime from the date of surgery to death by colon cancer

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026