NCT02789709

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 3, 2016

Status Verified

May 1, 2016

Enrollment Period

2.9 years

First QC Date

May 30, 2016

Last Update Submit

May 30, 2016

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    Time from the date of surgery to the date of first documentation of recurrence

    5 years from the date of surgery

Secondary Outcomes (5)

  • Disease-specific survival

    5 years from the date of surgery

  • Local recurrence

    5 years from the date of surgery

  • Systemic recurrence

    5 years from the date of surgery

  • Postoperative intra-abdominal sepsis

    30 days from the date of surgery

  • Postoperative mortality

    30 days from the date of surgery

Study Arms (1)

Non metastatic colon cancer patients

Consecutive patients undergoing elective surgery for non-metastatic colon or rectal cancer with curative intent.

Procedure: Surgery

Interventions

SurgeryPROCEDURE

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

Non metastatic colon cancer patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Non-metastatic colon and rectal cancer undergoing surgery with curative intent
  • Patients signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar Medical Research Institute

Barcelona, Barcelona, 08003, Spain

RECRUITING

Related Publications (8)

  • Pera M, Nelson H, Rajkumar SV, Young-Fadok TM, Burgart LJ. Influence of postoperative acute-phase response on angiogenesis and tumor growth: open vs. laparoscopic-assisted surgery in mice. J Gastrointest Surg. 2003 Sep-Oct;7(6):783-90. doi: 10.1016/s1091-255x(03)00111-2.

    PMID: 13129557RESULT

  • Bohle B, Pera M, Pascual M, Alonso S, Mayol X, Salvado M, Schmidt J, Grande L. Postoperative intra-abdominal infection increases angiogenesis and tumor recurrence after surgical excision of colon cancer in mice. Surgery. 2010 Jan;147(1):120-6. doi: 10.1016/j.surg.2009.06.035. Epub 2009 Sep 20.

    PMID: 19767043RESULT

  • Pascual M, Alonso S, Pares D, Courtier R, Gil MJ, Grande L, Pera M. Randomized clinical trial comparing inflammatory and angiogenic response after open versus laparoscopic curative resection for colonic cancer. Br J Surg. 2011 Jan;98(1):50-9. doi: 10.1002/bjs.7258. Epub 2010 Aug 26.

    PMID: 20799296RESULT

  • Pascual M, Bohle B, Alonso S, Mayol X, Salvans S, Grande L, Pera M. Preoperative administration of erythropoietin stimulates tumor recurrence after surgical excision of colon cancer in mice by a vascular endothelial growth factor-independent mechanism. J Surg Res. 2013 Jul;183(1):270-7. doi: 10.1016/j.jss.2012.12.041. Epub 2013 Jan 16.

    PMID: 23348072RESULT

  • Salvans S, Mayol X, Alonso S, Messeguer R, Pascual M, Mojal S, Grande L, Pera M. Postoperative peritoneal infection enhances migration and invasion capacities of tumor cells in vitro: an insight into the association between anastomotic leak and recurrence after surgery for colorectal cancer. Ann Surg. 2014 Nov;260(5):939-43; discussion 943-4. doi: 10.1097/SLA.0000000000000958.

    PMID: 25243554RESULT

  • Espin E, Ciga MA, Pera M, Ortiz H; Spanish Rectal Cancer Project. Oncological outcome following anastomotic leak in rectal surgery. Br J Surg. 2015 Mar;102(4):416-22. doi: 10.1002/bjs.9748. Epub 2015 Jan 26.

    PMID: 25619499RESULT

  • Alonso S, Pascual M, Salvans S, Mayol X, Mojal S, Gil MJ, Grande L, Pera M. Postoperative intra-abdominal infection and colorectal cancer recurrence: a prospective matched cohort study of inflammatory and angiogenic responses as mechanisms involved in this association. Eur J Surg Oncol. 2015 Feb;41(2):208-14. doi: 10.1016/j.ejso.2014.10.052. Epub 2014 Nov 1.

    PMID: 25468742RESULT

  • Montcusi B, Madrid-Gambin F, Pozo OJ, Marco S, Marin S, Mayol X, Pascual M, Alonso S, Salvans S, Jimenez-Toscano M, Cascante M, Pera M. Circulating metabolic markers after surgery identify patients at risk for severe postoperative complications: a prospective cohort study in colorectal cancer. Int J Surg. 2024 Mar 1;110(3):1493-1501. doi: 10.1097/JS9.0000000000000965.

    PMID: 38116682DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 3, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

June 3, 2016

Record last verified: 2016-05

Locations

ES(1)