The Role of Tumor-associated Macrophages in Colorectal Liver Metastases

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.

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Key information

Conditions

Colorectal Liver Metastases Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Immunotherapy Intestinal Diseases Intestinal Neoplasms Liver Metastases Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with colorectal liver metastases undergoing hepatectomy
Full clinical, surgical, pathological and follow-up data
Availability of tissues for the analysis

Exclusion criteria

Missing (any) data
Combination of radiofrequency or microwave ablation plus surgery

Treatment and study plan

Hepatectomy

Procedure

Removal of a part of the liver because of tumor

Other names: Liver resection

Primary outcomes

Survival

Time frame: From date of surgery until the date of first documented progression or date of death from any cause, which ever came first assessed up to 72 months]

Analysis of survival after hepatic resection for colorectal liver metastases according with the tumor-associated macrophages characteristics

Sponsors and collaborators

Lead sponsor

Humanitas Clinical and Research Center

Other

Registry information

Official study title

Search for the Clinical Significance of Tumor-associated Macrophages in Patients With Colorectal Liver Metastases

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2019
First posted: Mar 25, 2019
Registry last updated: Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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