Micrometastases and Angiogenesis in Colon Cancer. Prognostic Value of VEGF.

NCT04145505 | Unknown

• 1 other identifier: IIBSP-VEG-2018-77
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

According to current clinical guidelines adjuvant treatment in colon cancer is not recommended in patients with stage I and IIA, and in patients with high risk factors (IIB) adjuvant treatment has not shown a clear benefit in recurrence or survival. However, more than 20% of these patients have recurrence. This high percentage raises the possible understaging of current methods, so in recent years different methods have been developed in order to obtain a correct staging that have allowed a greater detection of micrometastasis (less than 2mm). The performance of the detection technique of the sentinel node in colon cancer allows us to perform this study in 1-3 lymph nodes, so that performing in all the nodes removed in a piece would be imposible in daily clinical practice for time, personnel and economic resources needed to do it. This technique achieves between 5-15% of overstaging which means that in stages I and IIA can lead to a change in the indication of adjuvant treatment. Despite this, the influence of ganglion micrometastases on survival is still controversial. This leads to consider other factors that may influence tumor aggressiveness, such as an increase in angiogenesis that allows the viability of implants less than 2mm. Therefore, we propose that elevated levels of VEGF (angiogenesis marker) in patients with sentinel lymph node micrometastases can lead to a worse prognosis. Based on these premises, the aim of the study is to assess the correlation between the levels of serum and tumor VEGF-A and VEGF-C (markers of angiogenesis and lymphangiogenesis) and the evolution of the disease in patients with lymph node micrometastases.

Conditions

Colorectal Cancer; Angiogenesis

Keywords

SENTINEL NODE

Outcome Measures

Primary Outcomes (1)

• recurrence

  local, lymph node or distant mtastasis appearance

  5 years

Interventions

COLORECTAL CANCER SURGERY PROCEDURE

SENTINEL NODE DETECTION

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 colonic cancer and curative surgery

You may qualify if:

• Patients older than 18 years
• Diagnosis of colon adenocarcinoma located above promontory
• Elective surgical treatment with oncological criteria and curative intention

You may not qualify if:

• Non-acceptance by the patient
• Patients who have received QT during the preoperative period
• Patients with previous colon surgery
• Patients with definitive study of the surgical piece with involvement of the lymph nodes according to conventional histological study (Stage III)
• Patients presenting distant dissemination in the extension study (Stage IV)

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood + tumor

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• CARMEN BALAGUÉ PONS, PHD DR

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IRENE GÓMEZ TORRES, PHD

CONTACT

+34 678309987; irenegomeztorres@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 26, 2019
• First Posted: October 30, 2019
• Study Start: October 26, 2019
• Primary Completion: February 21, 2020
• Study Completion: February 21, 2021
• Last Updated: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)