Immunoscore in Rectal Cancer

Study Overview
=================
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.

Official Title
-----------------
A Study to Determine the Immunopheotype of Locally Advanced Rectal Adenocarcinoma and Its Correlation With the Efficacy of Neoadjuvant Chemoradiotherapy

Conditions
-----------------
Cancer of the Rectum, Neoplasms, Rectal, Rectal Cancer, Rectal Tumors, Rectal Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: Diagnostic Biopsy and Surgical Procedure
* Procedure: Intravoxel incoherent motion MRI (IVIM)
* Procedure: Dynamic Contrast Enhanced MRI (DCE-MRI)
* Genetic: RNA gene expression analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rectal Cancer Patients<br>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. | Procedure: Diagnostic Biopsy and Surgical Procedure<br>* A tumor sample from the diagnostic biopsy and surgical procedure will be used for research.<br>Procedure: Intravoxel incoherent motion MRI (IVIM)<br>* At the end of a standard MRI, we will perform IVIM, which is a diffusion-weighted imaging sequence that simultaneously characterizes the microscopic diffusivity of water and the macroscopic transport of water via bulk flow. IVIM may more accurately reflect the properties of the tumor microenvironment including vascular permeability, interstitial fluid pressure, and response to neoadjuvant therapy.<br>Procedure: Dynamic Contrast Enhanced MRI (DCE-MRI)<br>* Following a standard MRI scan, Dynamic Contrast Enhanced MRI (DCE-MRI) will be done. DCE-MRI is an indicator-dilution experiment in which the delivery and transcapillary transfer of a contrast agent, typically one of a number of gadolinium-based contrast agents (GBCA), is used to assess a number of parameters characterizing tissue physiology. In locally advanced rectal cancer patients, use of DCE-MRI for determining pathologic response has produced equivocal results but more promising data has been published recently in the cervical cancer literature.<br>Genetic: RNA gene expression analysis<br>* RNA will be collected from biopsy and surgical tissue for gene expression analysis.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunoscore, Immunophenotype, MRI, RNA Later