Colorectal Cancer Clinical Trial
Official title:
Influence of the Presence of Ganglionar Micrometastases Associated With an Elevation of Angiogenesis on the Evolution of Colon Cancer. Prognostic Value of the Levels of VEGF-A Anf VEGF-C
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.
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).
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