Metabolomic Phenotyping After Surgery for Colon Cancer: Study of Novel Predictive Biomarkers
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|ClinicalTrials.gov Identifier: NCT02789709|
Recruitment Status : Unknown
Verified May 2016 by Miguel Pera, Parc de Salut Mar.
Recruitment status was: Recruiting
First Posted : June 3, 2016
Last Update Posted : June 3, 2016
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.
|Condition or disease||Intervention/treatment|
|Colon Cancer||Procedure: Surgery|
|Study Type :||Observational|
|Estimated Enrollment :||130 participants|
|Official Title:||Metabolomic Phenotyping After Surgery for Colon Cancer: Study of Novel Predictive Biomarkers|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Non metastatic colon cancer patients
Consecutive patients undergoing elective surgery for non-metastatic colon or rectal cancer with curative intent.
Segmental resection for colon cancer and anterior resection in patients with rectal cancer
- 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
- Disease-specific survival [ Time Frame: 5 years from the date of surgery ]Time from the date of surgery to death by colon cancer
- 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.
- 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
- Postoperative intra-abdominal sepsis [ Time Frame: 30 days from the date of surgery ]Anastomotic leak or intra-abdominal abscess
- Postoperative mortality [ Time Frame: 30 days from the date of surgery ]
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789709