Immunoscore in Rectal Cancer

NCT02017509 | Completed

• 1 other identifier: 13-107A
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Immunophenotype; Immunoscore; MRI; RNA Later

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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; Procedure: Intravoxel incoherent motion MRI (IVIM); Procedure: Dynamic Contrast Enhanced MRI (DCE-MRI); Genetic: RNA gene expression analysis

Interventions

Diagnostic Biopsy and Surgical Procedure PROCEDURE

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

Rectal Cancer Patients

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.

Rectal Cancer Patients

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.

Rectal Cancer Patients

RNA gene expression analysis GENETIC

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

Rectal Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of a rectal mass suspicious for or known to be an adenocarcinoma of the rectum.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Providence Health & Services: lead
• Oregon Health and Science University: collaborator

Study Sites (2)

Providence Health & Services

Portland, Oregon, 97213, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Links

• Providence Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Patients who enroll in the study will all undergo a biopsy as part of their standard of care evaluation. Biopsies samples will be obtained and sent to pathology for paraffin embedded blocks for diagnostic evaluation and for subsequent research. Patients will also have tissue stored in RNA later for subsequent microarray analysis.

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Marka Crittenden, MD, PhD

  Earle A. Chiles Research Institute at Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 20, 2013
• Study Start: January 24, 2014
• Primary Completion: July 17, 2018
• Study Completion: July 17, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data made available from study start to study closure (approximately 4 years).
• Access Criteria: Only de-identified data will be shared.

Locations

US (2)