Multicentric Breast CancerNCT04516330
Can MicroRNA's Predict Multicentricity in Breast Cancer?
A study testing miRNA in people with Multicentric Breast Cancer, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Multicentric Breast Cancer
- What is being tested?
- miRNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2014to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having breast cancer
- Having no other malignancy
- Female patient
Who cannot join
- Having other malignancy
- Under 18 years old
- Male patient
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multicentric Breast Cancer
- Being tested
- miRNA
- Keywords
- multicentric, breast, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miRNAGenetic
miRNA's expressed in breast cancer
| Study group | Role | What they receive |
|---|---|---|
| unifocal breast cancer | Active comparator | patients having unifocal breast cancer Receives: Genetic: miRNA |
| multicentric breast cancer | Active comparator | patients having multicentric breast cancer Receives: Genetic: miRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
MicroRNA's in multicentric breast cancer
Evaluation of 84 microRNA's in patients with multicentric breast cancer
Measured: April 2014
Secondary outcomes (1)
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
Measured: April 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study startFeb 2014
- Primary completionFeb 2016
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multicentric Breast CancerStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Emine Ersoy, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516330
- Sponsor's protocol ID
- MCBC-MIR
- Status last verified
- Aug 2020
- First submitted
- 10 Dec 2013
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can MicroRNA's Predict Multicentricity in Breast Cancer?
- ClinicalTrials.gov ID
- NCT04516330
- Acronym / sponsor ID
- MCBC-MIR
- Conditions
- Multicentric Breast Cancer
- Keywords
- multicentric, breast, cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unifocal breast cancer | Active comparator | Genetic: miRNApatients having unifocal breast cancer |
| multicentric breast cancer | Active comparator | Genetic: miRNApatients having multicentric breast cancer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having breast cancer
- Having no other malignancy
- Female patient
Key exclusion criteria (3 listed)
- Having other malignancy
- Under 18 years old
- Male patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miRNAmiRNA's expressed in breast cancer | Genetic | multicentric breast cancer, unifocal breast cancer |
Primary outcome
MicroRNA's in multicentric breast cancer
Time frame: April 2014
Evaluation of 84 microRNA's in patients with multicentric breast cancer
1 secondary outcome
Treatment plan according to the detected microRNA in patients with multicentric breast cancer
Time frame: April 2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miRNA in people with Multicentric Breast Cancer, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MicroRNA's in multicentric breast cancer (time frame: April 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.