Postoperative VEGF and Recurrence After Colon Cancer Surgery

• Conditions: Angiogenesis; Colon Cancer; Surgery; VEGF Overexpression; Recurrence
• Interventions: Procedure: Surgery for colon cancer with intention to cure

• Registration Number: NCT04851054
• Lead Sponsor: Hospital del Mar

Brief Summary

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.

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 Timeline

• Study Start: 2017-01-01
• Primary Completion: 2020-03-30
• Study First Submitted: 2021-03-11
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-14
• Last Update Submitted: 2021-04-14
• Study First Posted: 2021-04-20
• Last Update Posted: 2021-04-20
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients after surgery for colon cancer with intention to cure	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

Primary Outcome Measures

Name	Time	Method
VEGF in serum on postop day 4	Postoperative day 4	A 10cc sample of peripheral blood will be drawn on postoperative day 4