The Role of Tumor-associated Macrophages in Colorectal Liver Metastases

NCT03888638 | Completed

• 1 other identifier: TAMs in CLM
• Study Type: observational
• Target: 101
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Liver Metastases; Colorectal Cancer; Liver Metastases; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Survival

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

  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]

Interventions

Hepatectomy PROCEDURE

Removal of a part of the liver because of tumor

Also known as: Liver resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by colorectal liver metastases treated by hepatectomy.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Related Publications (1)

• Costa G, Sposito C, Soldani C, Polidoro MA, Franceschini B, Marchesi F, Nasir FD, Virdis M, Vingiani A, Leo A, Di Tommaso L, Kotha S, Mantovani A, Mazzaferro V, Donadon M, Torzilli G. Macrophage morphology and distribution are strong predictors of prognosis in resected colorectal liver metastases: results from an external retrospective observational study. Int J Surg. 2023 May 1;109(5):1311-1317. doi: 10.1097/JS9.0000000000000374.

  PMID: 37037585 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Specimens from liver resection

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Matteo Donadon, MD, PhD

  Humanitas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 25, 2019
• Study Start: January 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: March 1, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share