Postoperative VEGF and Recurrence After Colon Cancer Surgery

April 14, 2021 updated by: Marta Pascual, Hospital del Mar

Postoperative Serum VEGF Concentration as an Independent Prognostic Factor for Recurrence After Curative Colon Cancer Surgery. Multicentric Study.

The purpose of this trial is to study the relationship between the angiogenic response to surgical aggression, determined through the serum levels of vascular endothelial growth factor (VEGF) on postoperative day four, and the tumor recurrence in patients with colon cancer operated with a curative intention.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

DESIGN: Prospective multicentric study.

PARTICIPATION: Colorectal Surgery Units of Hospital del Mar, Barcelona; Hospital Universitari Joan XXIII, Tarragona; Hospital Universitari La Fe, Valencia; Hospital Clínico San Carlos, Madrid; Hospital General de Granollers, Granollers; Hospital Germans Trias i Pujol, Badalona; Athalaia, Xarxa Assistencial Universitària de Manresa, Manresa

STUDY SUBJECTS: 280 consecutive patients with non-metastatic colon cancer in whom a curative intent resection is performed.

DETERMINATIONS: Determination of the proangiogenic cytokine VEGF in serum on the postoperative day four to assess its relationship with oncological results on long-term follow-up.

Study Type

Observational

Enrollment (Anticipated)

280

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with colon cancer admitted to the Colorectal Surgery Unit of the centers participating in the study, who will undergo elective surgical resection with potentially curative intention.

Description

Inclusion Criteria:

  • Patients with colon cancer admitted to the Colorectal Surgery Unit of the centers participating in the study,
  • Patients who will undergo elective surgical resection with potentially curative intention

Exclusion Criteria:

  • Patients with metastatic disease
  • Patients with synchronous colon neoplasia or in the previous five years
  • Patients undergoing emergency surgery
  • Patients who do not sign the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients after surgery for colon cancer with intention to cure
Patients with colon cancer admitted to the Colorectal Surgery Unit of the centers participating in the study, who will undergo elective surgical resection with potentially curative intention
Procedure: Surgery for colon cancer with intention to cure
Surgery by open or laparoscopic approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VEGF in serum on postop day 4
Time Frame: Postoperative day 4
A 10cc sample of peripheral blood will be drawn on postoperative day 4
Postoperative day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Mar

Collaborators

Germans Trias i Pujol Hospital
Althaia Xarxa Assistencial Universitària de Manresa
Hospital Universitari Joan XXIII de Tarragona.
Hospital de Granollers

Investigators

  • Study Chair: MIGUEL PERA, PhD, Hospital del Mar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

March 30, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/6097/I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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