Immunoscore in Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017509
• Other study ID #: 13-107A
• Status: Completed
• Start date: January 24, 2014
• Est. completion date: July 17, 2018

Study information

• Verified date: August 2018
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Diagnostic Biopsy and Surgical Procedure
A tumor sample from the diagnostic biopsy and surgical procedure will be used for research.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon
United States	Providence Health & Services	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Providence Health & Services	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Providence Cancer Center