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NCT04851054 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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