Quantifying Micro RNA Levels of Colon (CRC)
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Purpose
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 |
|---|
|
Colorectal Carcinoma (CRC) Patients |
| Study Type: | Observational |
| 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 ]
Biospecimen Description:
human colon and rectal tumors, tumor adjacent and normal tissues
| Estimated Enrollment: | 100 |
| 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) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
CRC patients
Inclusion Criteria:
Adult men and women over the age of 18 years who underwent colon resection of any kind are suitable candidates for this study.
Exclusion Criteria:
Pregnant woman and children (under the age of 18 years) will not be included in this study.
Contacts and Locations| Contact: Shmuel Avital, M.D | 972-9-7472162 ext 2162 | avitalshmuel@gmail.com |
| Israel | |
| Meir Medical Center | Not yet recruiting |
| Kfar-Saba, Israel, 44281 | |
| Contact 972-9-7471753 | |
| Principal Investigator: | Shmuel Avital, M.D. | Meir Medical Center |
More Information
No publications provided
| Responsible Party: | Meir Medical Center |
| ClinicalTrials.gov Identifier: | NCT01712958 History of Changes |
| Other Study ID Numbers: | 0148 |
| Study First Received: | October 21, 2012 |
| Last Updated: | October 23, 2012 |
| Health Authority: | Israel: Clalit Health Services |
Keywords provided by Meir Medical Center:
|
CRC miRNA |
Additional relevant MeSH terms:
|
Carcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013