Immunoscore in Rectal Cancer

Completed

• Conditions: Rectal Cancer; Neoplasms, Rectal; Rectal Adenocarcinoma; Cancer of the Rectum; Rectal Tumors
• Interventions: Procedure: Diagnostic Biopsy and Surgical Procedure; Procedure: Intravoxel incoherent motion MRI (IVIM); Procedure: Dynamic Contrast Enhanced MRI (DCE-MRI); Genetic: RNA gene expression analysis

• Registration Number: NCT02017509
• Lead Sponsor: Providence Health & Services

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-20
• Study Start: 2014-01-24
• Primary Completion: 2018-07-17
• Study Completion: 2018-07-17
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Patients with a diagnosis of a rectal mass suspicious for or known to be an adenocarcinoma of the rectum.
• Age > 18
• Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.

Exclusion Criteria

• History of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer
• Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rectal Cancer Patients	RNA gene expression analysis	Patients with a diagnosis adenocarcinoma of the rectum will provide a tumor sample from their diagnostic biopsy and surgical procedure for research purposes, including RNA gene expression analysis. In addition to a standard MRI, patients will have an Intravoxel Incoherent Motion MRI (IVIM) and a Dynamic Contrast Enhanced MRI (DCE-MRI) for research purposes.
Rectal Cancer Patients	Diagnostic Biopsy and Surgical Procedure	Patients with a diagnosis adenocarcinoma of the rectum will provide a tumor sample from their diagnostic biopsy and surgical procedure for research purposes, including RNA gene expression analysis. In addition to a standard MRI, patients will have an Intravoxel Incoherent Motion MRI (IVIM) and a Dynamic Contrast Enhanced MRI (DCE-MRI) for research purposes.
Rectal Cancer Patients	Intravoxel incoherent motion MRI (IVIM)	Patients with a diagnosis adenocarcinoma of the rectum will provide a tumor sample from their diagnostic biopsy and surgical procedure for research purposes, including RNA gene expression analysis. In addition to a standard MRI, patients will have an Intravoxel Incoherent Motion MRI (IVIM) and a Dynamic Contrast Enhanced MRI (DCE-MRI) for research purposes.
Rectal Cancer Patients	Dynamic Contrast Enhanced MRI (DCE-MRI)	Patients with a diagnosis adenocarcinoma of the rectum will provide a tumor sample from their diagnostic biopsy and surgical procedure for research purposes, including RNA gene expression analysis. In addition to a standard MRI, patients will have an Intravoxel Incoherent Motion MRI (IVIM) and a Dynamic Contrast Enhanced MRI (DCE-MRI) for research purposes.

Primary Outcome Measures

Name	Time	Method
Correlation of the number of infiltrating leukocytes within a biopsy sample with pathologic response	16 weeks	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.

Trial Locations

Locations (2)

Providence Health & Services; 🇺🇸 Portland, Oregon, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States