Quantifying Micro RNA Levels of Colon (CRC)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01712958
First received: October 21, 2012
Last updated: October 23, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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
Study Population

CRC patients

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712958

Contacts
Contact: Shmuel Avital, M.D 972-9-7472162 ext 2162 avitalshmuel@gmail.com

Locations
Israel
Meir Medical Center Not yet recruiting
Kfar-Saba, Israel, 44281
Contact    972-9-7471753      
Sponsors and Collaborators
Meir Medical Center
Investigators
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 August 21, 2014