NCT04516330

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

December 10, 2013

Last Update Submit

August 14, 2020

Conditions

Multicentric Breast Cancer

Keywords

multicentricbreastcancer

Outcome Measures

Primary Outcomes (1)

  • MicroRNA's in multicentric breast cancer

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

    April 2014

Secondary Outcomes (1)

  • Treatment plan according to the detected microRNA in patients with multicentric breast cancer

    April 2014

Study Arms (2)

unifocal breast cancer

ACTIVE COMPARATOR

patients having unifocal breast cancer

Genetic: miRNA

multicentric breast cancer

ACTIVE COMPARATOR

patients having multicentric breast cancer

Genetic: miRNA

Interventions

miRNAGENETIC

miRNA's expressed in breast cancer

multicentric breast cancerunifocal breast cancer

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having breast cancer
  • Having no other malignancy
  • Female patient

You may not qualify if:

  • Having other malignancy
  • Under 18 years old
  • Male patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34306, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms

Interventions

MicroRNAs

Intervention Hierarchy (Ancestors)

RNA, AntisenseAntisense Elements (Genetics)Nucleic Acids, Nucleotides, and NucleosidesRNANucleic AcidsRNA, Small UntranslatedRNA, Untranslated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

December 10, 2013

First Posted

August 18, 2020

Study Start

February 1, 2014

Primary Completion

February 1, 2016

Study Completion

April 1, 2019

Last Updated

August 18, 2020

Record last verified: 2020-08

Locations

TU(1)