Cancer of the Rectum, Neoplasms, Rectal, Rectal Adenocarcinoma, Rectal Cancer, Rectal Tumors
Conditions
Keywords
Immunophenotype, Immunoscore, MRI, RNA Later
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.
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.
Interventions
PROCEDUREDiagnostic Biopsy and Surgical Procedure
A tumor sample from the diagnostic biopsy and surgical procedure will be used for research.
PROCEDUREIntravoxel 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.
PROCEDUREDynamic 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.
GENETICRNA gene expression analysis
RNA will be collected from biopsy and surgical tissue for gene expression analysis.
Sponsors
Oregon Health and Science University
Providence Health & Services
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed