Postoperative VEGF and Recurrence After Colon Cancer Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04851054
• Other study ID #: 2015/6097/I
• Status: Active, not recruiting
• Start date: January 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: Hospital del Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: December 31, 2021
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angiogenesis
• Colon Cancer
• Colonic Neoplasms
• Recurrence
• Surgery
• VEGF Overexpression

Intervention

Procedure:
• Surgery for colon cancer with intention to cure
Surgery by open or laparoscopic approach

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Hospital del Mar	Althaia Xarxa Assistencial Universitària de Manresa, Germans Trias i Pujol Hospital, Hospital de Granollers, Hospital Universitari Joan XXIII de Tarragona.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VEGF in serum on postop day 4	A 10cc sample of peripheral blood will be drawn on postoperative day 4	Postoperative day 4