Skip to main content
OpenTrials
Completed

NCT Number: NCT02017509

Immunoscore in Rectal Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer of the Rectum Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Neoplasms, Rectal Rectal Adenocarcinoma Rectal Cancer Rectal Diseases Rectal Neoplasms Rectal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University, Portland, Oregon, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic Biopsy and Surgical Procedure

Procedure

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

Intravoxel incoherent motion MRI (IVIM)

Procedure

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.

Dynamic Contrast Enhanced MRI (DCE-MRI)

Procedure

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.

RNA gene expression analysis

Genetic

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

Primary outcomes

  1. Correlation of the number of infiltrating leukocytes within a biopsy sample with pathologic response

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Providence Health & Services

Other

Collaborators

  • Oregon Health and Science University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2013
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.