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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02017509
Other study ID # 13-107A
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 24, 2014
Est. completion date July 17, 2018

Study information

Verified date August 2018
Source Providence Health & Services
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational study of tumor samples and MRI imaging in patients with colorectal cancers. A tumor sample, MRI scans, and treatment outcome data will be used for research purposes to see if it is possible to predict patients' response to treatment.


Description:

The quality of the immune environment in colorectal cancer biopsy samples correlates with disease-free survival and overall survival more so than current staging conventions. This study will use a scoring system called 'immunoscore' to characterize the immune enviroment. Researchers hypothesize that the immunoscore will correlate with outcomes of colorectal patients treated with neoadjuvant chemoradiation.


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Study Design


Intervention

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Locations

Country Name City State
United States Oregon Health & Science University Portland Oregon
United States Providence Health & Services Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
Providence Health & Services Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of the number of infiltrating leukocytes within a biopsy sample with pathologic response Quantitative immunohistochemical analysis will be performed on parameters of interest on both pre-treatment biopsy specimens as well as post-operative specimens. The pre-treatment sample will be used to establish the immunophenotype score. The primary analysis will evaluate the ability of immunophenotype score to correlate with pathologic response. 16 weeks
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