Premalignant LesionNCT04926688
High-risk Breast Lesions: A Multicenter Retrospective Study
An observational study of Premalignant Lesion, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
In this multicenter study, the goal was to document the excisional biopsy or follow-up results of high risk lesions diagnosed on image guided CNB/VAB, and evaluate the clinical, imaging and histologic features for associated malignancy risk. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Premalignant Lesion
- How many people
- 1,345 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2020to 10 Jun 2021
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The women with diagnosis of atypical ductal hyperplasia, lobular neoplasia, flat epithelial atypia, papilloma and radial scar on image guided core needle biopsy were studied
Who may be able to join
- Image guided needle biopsy diagnosis
- Atypical ductal hyperplasia
- Lobular neoplasia
- Flat epithelial atypia
- Papilloma
- Radial scar
- Diagnosed on image guided needle biopsy
Who cannot join
- Fibroepithelial tumors
- Mucocele like tumors
- Diagnosed on surgical biopsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of High-risk Breast Lesions Diagnosed on Image-guided Core Needle Biopsy: Results From a Multicenter Retrospective Study
In this multicenter study, the goal was to document the excisional biopsy or follow-up results of high risk lesions diagnosed on image guided CNB/VAB, and evaluate the clinical, imaging and histologic features for associated malignancy risk. The possibility of upgrade related to histologic subtype, tissue sampling and other variables was also evaluated.
Read the detailed description
This is a retrospective multicentric study that include 1345 patients from 30 centers.
Patients who had a diagnosis of high risk lesions (HRL) on image guided core biopsy (tru-cut/vacuum biopsy) were reviewed in a 12 year period (between 2008 and 2020). The lesions included were ADH, LN (ALH/LCIS), papilloma (without or with atypia), RS, and FEA.
The patients who managed with an excisional biopsy or having at least 1 year follow-up documentation following the diagnosis of borderline lesion were included in the study.
Radiological findings, diameter of lesion (>15 vs <15 mm), needle biopsy type (14-16G vs 9-12G), sampling method and number of samplings (4 and >4 vs <4) were documented.
IBM SPSS Version 25.0 statistical package program was used for analysis.
- Conditions
- Premalignant Lesion
What is being measured
The primary outcome is the main question the study is designed to answer.
upgrade rates related to histologic subtype, tissue sampling and other variables
the results from excisional biopsy or at least 1 year follow-up documentation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start10 Jun 2020
- Primary completion20 Jan 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premalignant LesionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Oktay, Ege University
- Investigators
- Aysenur Oktay, MD, Study chair, Ege UniversityOzge Aslan, MD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926688
- Sponsor's protocol ID
- 20-6T/41
- Status last verified
- Apr 2022
- First submitted
- 10 Jun 2021
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After finishing statistical analysis the results will be published
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of High-risk Breast Lesions Diagnosed on Image-guided Core Needle Biopsy: Results From a Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT04926688
- Acronym / sponsor ID
- 20-6T/41
- Conditions
- Premalignant Lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,345 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 15 Jun 2021 (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.
In this multicenter study, the goal was to document the excisional biopsy or follow-up results of high risk lesions diagnosed on image guided CNB/VAB, and evaluate the clinical, imaging and histologic features for associated malignancy risk. The possibility of upgrade related to histologic subtype, tissue sampling and other variables was also evaluated.
Detailed description
This is a retrospective multicentric study that include 1345 patients from 30 centers.
Patients who had a diagnosis of high risk lesions (HRL) on image guided core biopsy (tru-cut/vacuum biopsy) were reviewed in a 12 year period (between 2008 and 2020). The lesions included were ADH, LN (ALH/LCIS), papilloma (without or with atypia), RS, and FEA.
The patients who managed with an excisional biopsy or having at least 1 year follow-up documentation following the diagnosis of borderline lesion were included in the study.
Radiological findings, diameter of lesion (>15 vs <15 mm), needle biopsy type (14-16G vs 9-12G), sampling method and number of samplings (4 and >4 vs <4) were documented.
IBM SPSS Version 25.0 statistical package program was used for analysis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The women with diagnosis of atypical ductal hyperplasia, lobular neoplasia, flat epithelial atypia, papilloma and radial scar on image guided core needle biopsy were studied
Key inclusion criteria (7 listed)
- Image guided needle biopsy diagnosis
- Atypical ductal hyperplasia
- Lobular neoplasia
- Flat epithelial atypia
- Papilloma
Key exclusion criteria (3 listed)
- Fibroepithelial tumors
- Mucocele like tumors
- Diagnosed on surgical biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
upgrade rates related to histologic subtype, tissue sampling and other variables
Time frame: one year
the results from excisional biopsy or at least 1 year follow-up documentation
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 2 May 2022.
- Individual participant dataSharing planned: Yes. After finishing statistical analysis the results will be published
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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.
Aysenur Oktay, MD study chair
Ege University
Ozge Aslan, MD principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premalignant Lesion, run by Ege 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 7 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 2 May 2022. 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?
upgrade rates related to histologic subtype, tissue sampling and other variables (time frame: one year). 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 2 May 2022.