Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646341
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
EMVI as a Determinant of Metastasis in Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EMVI as a Determinant of Metastasis in Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVIDENCE
Brief Summary:
Bowel cancer is the fourth most commonly occurring cancer and the second highest cause of cancer deaths in the UK Despite advances in treatment over 40 of patients will die within 5 years This is normally due to spread of the cancer to other organs called metastases Much of the current research focuses on use of additional treatments such as radiotherapy and chemotherapy before or after surgery adjuvant treatment It is of vital importance that patients who would benefit from adjuvant treatment can be accurately identified At the moment the system used locally to do this places emphasis on the presence of affected lymph nodes glands This is because doctors believe that cancer spreads to other organs through the lymphatic system However recent studies have suggested that this is not the case
It is believed that cancer spreads to other organs through the blood stream rather than the lymph node system This research will look at the genetic material in tumours and metastases as well as in areas of blood vessel invasion and lymph nodes The analysis will allow us to build a family tree of the tumour and allow us to map the pathway by which the tumour spreads Tissue samples already collected through a patients routine care will be used for this study If the spread through the blood vessels is proven this would change the way in which patients are selected for treatment and allow development of new treatments to target these pathways
It is believed that cancer spreads to other organs through the blood stream rather than the lymph node system This research will look at the genetic material in tumours and metastases as well as in areas of blood vessel invasion and lymph nodes The analysis will allow us to build a family tree of the tumour and allow us to map the pathway by which the tumour spreads Tissue samples already collected through a patients routine care will be used for this study If the spread through the blood vessels is proven this would change the way in which patients are selected for treatment and allow development of new treatments to target these pathways
Detailed Description:
A retrospective non-interventional tissue study using archival materials collected through a patients routine care EVIDENCE aims to demonstrate that distant metastases in colorectal cancer are related to EMVI and tumour deposits not lymph nodes As EVIDENCE is a retrospective study there are no time dependent schedules for CRF completion or tissue submission
It will be tesed whether the vascular route of spread as evidenced through EMVI and tumour deposits is more important than lymph nodes in the development of metastatic disease The subclonal origins of primary colorectal cancers EMVI tumour deposits lymph nodes and distant metastases by reconstructing phylogenetic trees will be compared A proof for a vascular route of spread rather than lymph nodes would lead to a paradigm shift in future decision making at national and international level
It will be tesed whether the vascular route of spread as evidenced through EMVI and tumour deposits is more important than lymph nodes in the development of metastatic disease The subclonal origins of primary colorectal cancers EMVI tumour deposits lymph nodes and distant metastases by reconstructing phylogenetic trees will be compared A proof for a vascular route of spread rather than lymph nodes would lead to a paradigm shift in future decision making at national and international level
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None