An observational study in Colorectal Cancer and Angiogenesis, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-30.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational
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).
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with colonic cancer and curative surgery
Exclusion criteria:
SENTINEL NODE DETECTION
recurrence
local, lymph node or distant mtastasis appearance
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Neoplasm Micrometastasis
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau