Immunoscore in Rectal Cancer

Sponsor

Providence Health & Services (Other)

Overall Status

Completed

CT.gov ID

NCT02017509

Collaborator

Oregon Health and Science University (Other)

Enrollment

Locations

53.7

Actual Duration (Months)

1.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of the Rectum Neoplasms, Rectal Rectal Cancer Rectal Tumors Rectal Adenocarcinoma	Procedure: Diagnostic Biopsy and Surgical Procedure Procedure: Intravoxel incoherent motion MRI (IVIM) Procedure: Dynamic Contrast Enhanced MRI (DCE-MRI) Genetic: RNA gene expression analysis

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 Design

Study Type:

Observational

Actual Enrollment :

3 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 24, 2014

Actual Primary Completion Date :

Jul 17, 2018

Actual Study Completion Date :

Jul 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Rectal Cancer Patients 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 A tumor sample from the diagnostic biopsy and surgical procedure will be used for research. Procedure: Intravoxel incoherent motion MRI (IVIM) 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. Procedure: Dynamic Contrast Enhanced MRI (DCE-MRI) 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. Genetic: RNA gene expression analysis RNA will be collected from biopsy and surgical tissue for gene expression analysis.

Arm

Intervention/Treatment

Rectal Cancer Patients

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

A tumor sample from the diagnostic biopsy and surgical procedure will be used for research.

Procedure: Intravoxel incoherent motion MRI (IVIM)

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.

Procedure: Dynamic Contrast Enhanced MRI (DCE-MRI)

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.

Genetic: RNA gene expression analysis

RNA will be collected from biopsy and surgical tissue for gene expression analysis.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.