Can MicroRNA's Predict Multicentricity in Breast Cancer?

August 14, 2020 updated by: Yeliz Emine Ersoy, Bezmialem Vakif University
The aim of this study is to determine if microRNA's have role in predicting multicentricity in breast cancer. If a specific microRNA will be found to be related with multicentricity, it will help us to make appropriate decisions on the treatment of patients with multicentric breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the study that will be held at Bezmialem Vakif University Medical Faculty, General Surgery Department, 20 unifocal and 20 multifocal breast cancer patients will be included. Tissues will be taken from both tumoral and normal breast tissues and they will be saved in microRNA later solution under -80°C. Then, 84 microRNA's will be studied in these tissues to see if they express any of these microRNA's.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34306
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Having breast cancer
  2. Having no other malignancy
  3. Female patient

Exclusion Criteria:

  1. Having other malignancy
  2. Under 18 years old
  3. Male patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: unifocal breast cancer
patients having unifocal breast cancer
Genetic: miRNA
miRNA's expressed in breast cancer
Active Comparator: multicentric breast cancer
patients having multicentric breast cancer
Genetic: miRNA
miRNA's expressed in breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MicroRNA's in multicentric breast cancer
Time Frame: April 2014
Evaluation of 84 microRNA's in patients with multicentric breast cancer
April 2014

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment plan according to the detected microRNA in patients with multicentric breast cancer
Time Frame: April 2014
If a specific microRNA will be detected in patients with multicentric breast cancer, treatment plan will be individualized according to the detected microRNA
April 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

August 14, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCBC-MIR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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