Quantifying Micro RNA Levels of Colon (CRC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01712958|
Recruitment Status : Unknown
Verified October 2012 by Meir Medical Center.
Recruitment status was: Not yet recruiting
First Posted : October 24, 2012
Last Update Posted : October 24, 2012
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.
|Condition or disease|
|Colorectal Carcinoma (CRC) Patients|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Quantifying Micro RNA Levels to Obtain a Micro RNA Signature of Colon Tumor Phenotypes and Sub Phenotypes|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||November 2015|
- identifying specific, relevant miRNAs that may serve as biomarkers to stratify CRC patients according to their clinical characteristics [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712958
|Contact: Shmuel Avital, M.D||972-9-7472162 ext firstname.lastname@example.org|
|Meir Medical Center||Not yet recruiting|
|Kfar-Saba, Israel, 44281|
|Principal Investigator:||Shmuel Avital, M.D.||Meir Medical Center|