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

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ClinicalTrials.gov Identifier: NCT02789709
Recruitment Status : Recruiting
First Posted : June 3, 2016
Last Update Posted : June 3, 2016
Sponsor:
Collaborator:
University of Barcelona
Information provided by (Responsible Party):
Miguel Pera, Parc de Salut Mar

Tracking Information
First Submitted Date May 30, 2016
First Posted Date June 3, 2016
Last Update Posted Date June 3, 2016
Study Start Date January 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2016)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 30, 2016)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Metabolomic Phenotyping After Surgery for Colon Cancer: Study of Novel Predictive Biomarkers
Official Title Metabolomic Phenotyping After Surgery for Colon Cancer: Study of Novel Predictive Biomarkers
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma
Sampling Method Probability Sample
Study Population Consecutive patients undergoing surgery for colon and rectal cancer with curative intent
Condition Colon Cancer
Intervention Procedure: Surgery
Segmental resection for colon cancer and anterior resection in patients with rectal cancer
Study Groups/Cohorts Non metastatic colon cancer patients
Consecutive patients undergoing elective surgery for non-metastatic colon or rectal cancer with curative intent.
Intervention: Procedure: Surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 30, 2016)
130
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02789709
Other Study ID Numbers PI15/00458
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Miguel Pera, Parc de Salut Mar
Study Sponsor Parc de Salut Mar
Collaborators University of Barcelona
Investigators Not Provided
PRS Account Parc de Salut Mar
Verification Date May 2016