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Comprehensive Immune-landscape in Localized Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02138370
Recruitment Status : Unknown
Verified May 2015 by University of Zurich.
Recruitment status was:  Active, not recruiting
First Posted : May 14, 2014
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
Medical University of Graz
Information provided by (Responsible Party):
University of Zurich

Brief 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.


Condition or disease
Colorectal Cancer Immune Landscape

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Tissue Und Liquid Immune Biopsies to Predict Clinical Outcome in Localized Colorectal Cancer Patients - Retrospective Clinical Observational Study.
Study Start Date : April 2015
Estimated Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort
stage II and III colorectal cancer



Primary Outcome Measures :
  1. Time to disease recurrence [ Time Frame: 16 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 16 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with histopathologically confirmed stage II and III colon cancer consecutively enrolled at the Division of Clinical Oncology, Department of Medicine, Medical University of Graz (Graz, Austria) between 1995 and 2011.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138370


Locations
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Switzerland
University Hospital Zuerich
Zuerich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Medical University of Graz
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02138370    
Other Study ID Numbers: Immuno_CRC_001
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases