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
About this trial
This is an interventional diagnostic trial for Multicentric Breast Cancer focused on measuring multicentric, breast, cancer
Eligibility Criteria
Inclusion Criteria:
- Having breast cancer
- Having no other malignancy
- Female patient
Exclusion Criteria:
- Having other malignancy
- Under 18 years old
- 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
NCT ID
NCT04516330
First Posted
December 10, 2013
Last Updated
August 14, 2020
Sponsor
Bezmialem Vakif University
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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