NCT03888638

The Role of Tumor-associated Macrophages in Colorectal Liver Metastases

Completed Last updated 25 March 2019

What this trial tests

trial testing Hepatectomy in Colorectal Liver Metastases in 101 participants. Completed in 1 March 2019.

Timeline

1 January 2015

Primary endpoint
31 December 2017

1 March 2019

Quick facts

Lead sponsor	Humanitas Clinical and Research Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	101
Start date	1 January 2015
Primary completion	31 December 2017
Estimated completion	1 March 2019

Drugs / interventions tested

• Hepatectomy

Conditions studied

• Colorectal Liver Metastases — all drugs for Colorectal Liver Metastases →
• Colorectal Cancer — all drugs for Colorectal Cancer →
• Liver Metastases — all drugs for Liver Metastases →
• Immunotherapy — all drugs for Immunotherapy →

Sponsor

Humanitas Clinical and Research Center

Who can join

18 and older, any sex, with Colorectal Liver Metastases or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Macrophage morphology correlates with single-cell diversity and prognosis in colorectal liver metastasis.
   Donadon M, Torzilli G, Cortese N, Soldani C, et al · · 2020 · cited 134× · PMID 32785653 · DOI 10.1084/jem.20191847
2. Unraveling the enigma of tumor-associated macrophages: challenges, innovations, and the path to therapeutic breakthroughs.
   Shao S, Miao H, Ma W. · · 2023 · cited 45× · PMID 38035068 · DOI 10.3389/fimmu.2023.1295684
3. Tumor-associated macrophages within the immunological milieu: An emerging focal point for therapeutic intervention.
   Shao Y, Han S, Hou Z, Yang C, et al · · 2024 · cited 15× · PMID 39281573 · DOI 10.1016/j.heliyon.2024.e36839
4. Riboflavin-LSD1 axis participates in the in vivo tumor-associated macrophage morphology in human colorectal liver metastases.
   Soldani C, De Simone G, Polidoro MA, Morabito A, et al · · 2024 · cited 8× · PMID 38430255 · DOI 10.1007/s00262-024-03645-1
5. Macrophage morphology and distribution are strong predictors of prognosis in resected colorectal liver metastases: results from an external retrospective observational study.
   Costa G, Sposito C, Soldani C, Polidoro MA, et al · · 2023 · cited 8× · PMID 37037585 · DOI 10.1097/js9.0000000000000374