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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 : 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
Sponsor:
Collaborator:
University of Barcelona
Information provided by (Responsible Party):
Miguel Pera, Parc de Salut Mar

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.


Condition or disease Intervention/treatment
Colon Cancer Procedure: Surgery

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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Disease-specific survival [ Time Frame: 5 years from the date of surgery ]
    Time from the date of surgery to death by colon cancer

  2. 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.

  3. 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

  4. Postoperative intra-abdominal sepsis [ Time Frame: 30 days from the date of surgery ]
    Anastomotic leak or intra-abdominal abscess

  5. Postoperative mortality [ Time Frame: 30 days from the date of surgery ]

Biospecimen Retention:   Samples Without DNA
Plasma


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients undergoing surgery for colon and rectal cancer with curative intent
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789709


Locations
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Spain
Hospital del Mar Medical Research Institute Recruiting
Barcelona, Spain, 08003
Contact: Miguel Pera, MDPhD    34932483207    mpera@hospitaldelmar.cat   
Contact: Marta Pascual, MDPhD    34932483207    mpascual@hospitaldelmar.cat   
Sponsors and Collaborators
Parc de Salut Mar
University of Barcelona

Publications of Results:

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Responsible Party: Miguel Pera, MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02789709     History of Changes
Other Study ID Numbers: PI15/00458
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases