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Can MicroRNA's Predict Multicentricity in Breast Cancer?

Primary Purpose

Multicentric Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
miRNA
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multicentric Breast Cancer focused on measuring multicentric, breast, cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakif University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

unifocal breast cancer

multicentric breast cancer

Arm Description

patients having unifocal breast cancer

patients having multicentric breast cancer

Outcomes

Primary Outcome Measures

MicroRNA's in multicentric breast cancer
Evaluation of 84 microRNA's in patients with multicentric breast cancer

Secondary Outcome Measures

Treatment plan according to the detected microRNA in patients with multicentric breast cancer
If a specific microRNA will be detected in patients with multicentric breast cancer, treatment plan will be individualized according to the detected microRNA

Full Information

First Posted
December 10, 2013
Last Updated
August 14, 2020
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04516330
Brief Title
Can MicroRNA's Predict Multicentricity in Breast Cancer?
Official Title
Can MicroRNA's Predict Multicentricity in Breast Cancer?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multicentric Breast Cancer
Keywords
multicentric, breast, cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
unifocal breast cancer
Arm Type
Active Comparator
Arm Description
patients having unifocal breast cancer
Arm Title
multicentric breast cancer
Arm Type
Active Comparator
Arm Description
patients having multicentric breast cancer
Intervention Type
Genetic
Intervention Name(s)
miRNA
Intervention Description
miRNA's expressed in breast cancer
Primary Outcome Measure Information:
Title
MicroRNA's in multicentric breast cancer
Description
Evaluation of 84 microRNA's in patients with multicentric breast cancer
Time Frame
April 2014
Secondary Outcome Measure Information:
Title
Treatment plan according to the detected microRNA in patients with multicentric breast cancer
Description
If a specific microRNA will be detected in patients with multicentric breast cancer, treatment plan will be individualized according to the detected microRNA
Time Frame
April 2014

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having breast cancer Having no other malignancy Female patient Exclusion Criteria: Having other malignancy Under 18 years old Male patient
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
ZIP/Postal Code
34306
Country
Turkey

12. IPD Sharing Statement

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Can MicroRNA's Predict Multicentricity in Breast Cancer?

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