Ignite Creation Date:
2024-05-06 @ 12:55 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03888638
Status:
COMPLETED
Last Update Posted:
2019-03-25
First Post:
2019-03-21
Brief Title:
The Role of Tumor-associated Macrophages in Colorectal Liver Metastases
Sponsor:
Humanitas Clinical and Research Center
Organization:
Humanitas Clinical and Research Center
Study Overview
Official Title:
Search for the Clinical Significance of Tumor-associated Macrophages in Patients With Colorectal Liver Metastases
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
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:
None
Brief Summary:
Colorectal cancer is a major cause of mortality worldwide Most patients develop colorectal liver metastases CLM and for such patients hepatectomy combined with chemotherapy may be curative Nevertheless in the era of precision medicine there is a critical need of prognostic markers to cope with the heterogeneity of CLM patients Tumor-associated macrophages TAMs pave the way to tissue invasion and intravasation providing a nurturing microenvironment formetastases The quantification of immune landscape of tumors has provided novel prognostic indicators of cancer progression and the quantification of TAMs might explain the heterogeneity of CLM patients Here we will investigate the development of a new diagnostic tool based on TAMs with the aim to define the causative role of TAMs in CLM patients This will open new clinical scenarios both for the diagnosis therapy and prognosis leading to the refinement of the therapeutic output in a personalized medicine perspective
Detailed Description:
Some preliminary data produced by the research team from Humanitas Clinical and Research Center in Milan ITALY have shown that TAMs in CLM are heterogeneous and that their diversity can be distinguished based on their morphology and functionality Therefore TAMs may represent an additional tool in the definition of the biology and prognosis of CLM patients This preliminary finding provides us with the rationale to undertake a prospective study on a large series of CLM patients surgically resected by our unit aimed at validating the promisingcorrelation between different TAMs phenotypes and patients prognosis The characterization of the diversity of TAMs in CLM will be refined using state of the art technology including multi-parametric flow cytometry single cell RNA sequencing scRNA-seq transcriptional profiling metabolomic and proteomic analyses The expected findings will allow us to develop a new diagnostic tool based on TAMs features which will open the way to new criteria for patient stratification and for the design of new targeted therapies in a personalized medicine perspective
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