Overview

This trial is active, not recruiting.

Conditions colorectal cancer, immune landscape
Sponsor University of Zurich
Collaborator Medical University of Graz
Start date April 2015
End date September 2016
Trial size 300 participants
Trial identifier NCT02138370, Immuno_CRC_001

Summary

Surgery still remains the mainstay of treatment for localized colorectal cancer. However, nearly 30% of patients with localized colorectal cancer (stage II and stage III) will present with recurrence. Tumor progression is mediated by both intrinsic genetic changes and by extrinsic epigenetic and host environmental factors, including interactions with the immune system. Several studies demonstrated that tumor infiltrating memory T-cells and type, density and location of infiltrating T cells are better predictors of disease-free survival in patients with CRC compared to the standard TNM staging. These data suggest that tumor invasion and progression are more accurately predicted by immune response in the primary tumor. In addition, mismatch repair (MMR)-deficient tumors are characterized a priori by a higher frequency of tumor infiltrating lymphocytes and are associated with significantly improved prognosis. Recently, Stotz et al showed that the preoperative lymphocyte to monocyte ratio in peripheral blood samples predicts clinical outcome in patients with stage III colon cancer. So far there is no comprehensive analysis of the immune-landscape in CRC.

The aim of the current project is to identify a comprehensive panel of immunomarkers in localized colorectal cancer (stage II and stage III) applicable for the detection of patients at high risk of recurrence. For the first time, specific tumor-infiltrating immune cells, mismatch repair protein expression in tumor tissue and preoperative blood based inflammatory markers from routine blood counts in corresponding peripheral blood samples and known clinicopathological features will be correlated with outcome in 300 localized CRC patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm

Primary Outcomes

Measure
Time to disease recurrence
time frame: 16 years

Secondary Outcomes

Measure
overall survival
time frame: 16 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Male and Female patients ≥ 18 years of age; - Formalin fixed paraffin embedded (FFPE) tissue samples of stage II and stage III colorectal cancer patients consecutively enrolled at the Division of Clinical Oncology, Department of Med.University of Graz (Graz, Austria) between 1995 - 2011 Exclusion Criteria: - Male and Female patients < 18 years of age

Additional Information

Official title Tissue Und Liquid Immune Biopsies to Predict Clinical Outcome in Localized Colorectal Cancer Patients - Retrospective Clinical Observational Study.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Zurich.