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

NCT ID: NCT04145505

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-26
• Study Completion Date: 2021-02-21

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.

Detailed Description

Once the investigators have all the data of the patients included in the study, and the ELISA analysis of the serum and tissue VEGF levels has been performed, we hope to determine a threshold level of VEGF in blood and tissue that modifies the prognostic implications of the presence of ganglionic micrometastasis, which increases the viability of these implants.

If the investigators determine this threshold and demonstrate that high levels of this molecule, both in blood and tissue, increase the rate of recurrence in patients with lymph node micrometastases, would be suggested a change in the indications for adjuvant treatment in patients in whom it is not currently indicated (stages I-IIA and IIB without other factors of poor prognosis) considering that they have an independent bad prognostic factor such as a high level (above our threshold) of VEGF. This allows the investigators to select those patients who would benefit from chemotherapy treatment despite not being indicated according to the current treatment guidelines (NCCN 2018).

Conditions

Colorectal Cancer; Angiogenesis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

COLORECTAL CANCER SURGERY

SENTINEL NODE DETECTION

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

M. Carmen Balague Ponz

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

CARMEN BALAGUÉ PONS, PHD DR

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

IRENE GÓMEZ TORRES, PHD

Role: CONTACT

irenegomeztorres@gmail.com

+34 678309987

Facility Contacts

Maria Carmen Balagué Ponz, MD

Role: primary

cbalague@santpau.cat

+34 93 556 56 71

Eduardo Maria Targarona Soler, MD PhD

Role: backup

etargarona@santpau.cat

+34 93 556 56 71

Other Identifiers

IIBSP-VEG-2018-77

Identifier Type: -

Identifier Source: org_study_id