Ignite Creation Date:
2024-05-06 @ 1:51 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04145505
Status:
UNKNOWN
Last Update Posted:
2019-10-30
First Post:
2019-10-26
Brief Title:
Micrometastases and Angiogenesis in Colon Cancer Prognostic Value of VEGF
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VEGF-GC
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None