Comprehensive Immune-landscape in Localized Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Tissue Und Liquid Immune Biopsies to Predict Clinical Outcome in Localized Colorectal Cancer Patients - Retrospective Clinical Observational Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02138370
• Other study ID #: Immuno_CRC_001
• Status: Active, not recruiting
• Phase: N/A
• First received: May 12, 2014
• Last updated: May 27, 2015
• Start date: April 2015

Study information

• Verified date: May 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Immune Landscape

Locations

Country	Name	City	State
Switzerland	University Hospital Zuerich	Zuerich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Medical University of Graz

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to disease recurrence		16 years	No
Secondary	overall survival		16 years	No