Postoperative VEGF and Recurrence After Colon Cancer Surgery

NCT04851054 | Unknown DMC

• 1 other identifier: 2015/6097/I
• Study Type: observational
• Target: 280
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Angiogenesis; Colon Cancer; Surgery; Recurrence; VEGF Overexpression

Keywords

VEGF; Colon Cancer; Surgery; Recurrence

Outcome Measures

Primary Outcomes (1)

• VEGF in serum on postop day 4

  A 10cc sample of peripheral blood will be drawn on postoperative day 4

  Postoperative day 4

Study Arms (1)

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

Interventions

Surgery for colon cancer with intention to cure PROCEDURE

Surgery by open or laparoscopic approach

Patients after surgery for colon cancer with intention to cure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital del Mar: lead
• Germans Trias i Pujol Hospital: collaborator
• Hospital de Granollers: collaborator
• Althaia Xarxa Assistencial Universitària de Manresa: collaborator
• Hospital Universitari Joan XXIII de Tarragona.: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples stored at -80ºC

MeSH Terms

Conditions

Colonic Neoplasms; Recurrence

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MIGUEL PERA, PhD

  Hospital del Mar

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CHIEF, COLON AND RECTAL SURGERY, DEPARTMEN OF SURGERY

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: April 20, 2021
• Study Start: January 1, 2017
• Primary Completion: March 30, 2020
• Study Completion: December 31, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share