Quantifying Micro RNA Levels of Colon (CRC)
Recruitment status was: Not yet recruiting
Colorectal cancer (CRC) is the third most common cancer and the fourth leading cause of cancer-related death in the world. Despite potentially curative surgery and the use of modern adjuvant chemotherapy, up to 40% of CRC patients subsequently develop local tumor relapse or metastatic disease. Currently, aside from post-operative pathological staging, early follow up of the patients does not include a specific test or any other evaluation that could predict disease recurrence. Therefore, exploring and identifying novel biomarkers of CRC's following diagnosis of the primary tumor may help us in identifying patients at high risk for recurrence.
Modifications in signaling pathways and their regulation by microRNAs (miRNAs) are being evaluated as biomarkers and therapeutic targets for cancer in general and CRC in particular. It has been established, although not completely, that miRNAs have a role in initiation and progression of CRC. Modifications of miRNAs have been recorded in CRC tumors, and the expression patterns of these miRNAs could in principle biomark this cancer's phenotype. As miRNAs are well documented to regulate critical molecules in signaling pathways, their regulation of tumor relevant pathways may also serve to further sub-classify patients into drug responsive groups. Moreover, miRNAs may be sampled from peripheral blood and are available as a non-invasive diagnostic method, their application as biomarkers is of special interest.
In this study the investigators aim to quantify miRNA levels in human colon and rectal tumors, tumor adjacent and normal tissues. By comparing this data from a large cohort of patients, the investigators aim to identify specific, relevant miRNAs that may serve as biomarkers to stratify CRC patients according to their clinical characteristics such as disease stage, specific treatment, prognosis and disease recurrence.
Colorectal Carcinoma (CRC) Patients
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Quantifying Micro RNA Levels to Obtain a Micro RNA Signature of Colon Tumor Phenotypes and Sub Phenotypes|
- identifying specific, relevant miRNAs that may serve as biomarkers to stratify CRC patients according to their clinical characteristics [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712958
|Meir Medical Center|
|Kfar-Saba, Israel, 44281|
|Principal Investigator:||Shmuel Avital, M.D.||Meir Medical Center|