Immunoscore in Rectal Cancer

Providence Health & Services

Status: Completed

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT02017509

13-107A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3 participants in 1 patient group

Rectal Cancer Patients

Description:

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.

Treatment:

Procedure: Diagnostic Biopsy and Surgical Procedure

Procedure: Intravoxel incoherent motion MRI (IVIM)

Genetic: RNA gene expression analysis

Procedure: Dynamic Contrast Enhanced MRI (DCE-MRI)