NCT02017509

Immunoscore in Rectal Cancer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer of the Rectum
• Neoplasms, Rectal
• Rectal Cancer
• Rectal Tumors
• Rectal Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-01-24
• Primary completion: 2018-07-17
• Completion: 2018-07-17
• First posted: 2013-12-20
• Last updated: 2018-08-29

Locations

2 sites across 1 country: United States