Neoplasms

All Conditions

Digestive System Diseases

Adenocarcinoma

Rectal Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

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.

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

Diagnostic Biopsy and Surgical 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.

Intravoxel incoherent motion MRI (IVIM)

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.

Dynamic Contrast Enhanced MRI (DCE-MRI)

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

RNA gene expression analysis

Marka Crittenden, MD, PhD

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.

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.

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.

Immunoscore in Rectal Cancer

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

This project is being done to contribute pathology samples and patient outcome data to a larger data set intended to validate an algorithm to predict patient outcome based on pathology data obtained at diagnosis. As part of this project, pre-existing samples will be used. There will be new slides made from the samples that will be stained to identify immune response. Pathology analysis and images of the slides will be provided (without patient identifiers) along with de-identified patient outcome data to a central coordinating center.

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.

Oregon Health and Science University

Providence Health & Services

Symptoms and General Pathology

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

The study population will comprise 200 (two hundred) adult patients candidate to neurosurgical treatment for newly diagnosed malignant brain tumors, able to express an informed consent.

Blood samples will be tested with flow cytometry in order to characterize leukocyte subpopulations and to evaluate the circulating immunophenotype

Circulating leukocytes immunophenotype

Immunohistochemical analysis will be performed on tumor samples in order to characterize immune T cells distribution within the tumor.

Tumor sampling

Laura Sincinelli

Pietro Mortini, MD, Prof.

The goal of this observational study is to characterize the circulating leukocyte profile and the immune T cells distribution within the tumor in patients with malignant brain tumors and to correlate these findings with the oncological outcome.

Participants will be subjected to blood sampling before surgery and for 12 months of follow-up. Additional sampling and analysis will be performed on tumor samples.

High-grade gliomas are the most frequent type of primary brain tumor in adults, and among them, glioblastoma multiforme (GBM) is the most malignant with an associated poor prognosis. Although significant advances have been achieved in GBM biology comprehension, patients' life expectancy is still limited to 18 months.

Brain metastases (BM) are the most frequent neoplasm in the CNS; it is estimated that up to 14% of all newly diagnosed cancers will soon or later metastasize into the brain.

A variety of mechanisms to escape a tumor-specific T cell-mediated immune response have been identified in glioma and other cancer entities.

This project is an observational, prospective, monocentric study on patients candidates for neurosurgical procedures for brain malignant tumors with additional collection of biological material. With the present study, we aim to characterize the phenotype of both circulating- and tumor-infiltrating- immune cells at the diagnosis and their changes during disease progression and after treatment in primary and secondary brain tumors.

Samples will be taken at baseline (before surgery) and at time-points: 3, 6, 9, 12 months

Blood samples for lymphocyte extraction and immunophenotype detection.

Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain Tumors

Immunophenotype Characterization of Circulating and Tumor Infiltrating Immune Cells in Malignant Brain Tumors.

Leucocytes count (10\^3/ml), total lymphocytes count (10\^3/ml)

Determination of different leucocyte subpopulations (%)

Infiltrating lymphocytes count (10\^3/ml)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Immunoscore in Rectal Cancer	NCT02017509	Cancer of the R... Neoplasms, Rect... Rectal Cancer Rectal Tumors Rectal Adenocar...	Diagnostic Biop... Intravoxel inco... Dynamic Contras... RNA gene expres...	18 Years -	Providence Health & Services
Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain Tumors	NCT05831631	Brain Tumor, Pr... Brain Tumor - M...	Circulating leu... Tumor sampling	18 Years -	IRCCS San Raffaele

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