Premalignant Lesion Clinical Trial
Official title:
Outcome of High-risk Breast Lesions Diagnosed on Image-guided Core Needle Biopsy: Results From a Multicenter Retrospective Study
NCT number | NCT04926688 |
Other study ID # | 20-6T/41 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 10, 2020 |
Est. completion date | June 10, 2021 |
Verified date | April 2022 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1345 |
Est. completion date | June 10, 2021 |
Est. primary completion date | January 20, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 Sampling Method: Non-Probability Sample Minimum Age: 12 Maximum Age: 86 Sex: Female Gender Based: No Accepts Healthy Volunteers: No Criteria: Inclusion Criteria: - Image guided needle biopsy diagnosis - Atypical ductal hyperplasia - Lobular neoplasia - Flat epithelial atypia - Papilloma - Radial scar - Diagnosed on image guided needle biopsy Exclusion Criteria: - Fibroepithelial tumors - Mucocele like tumors - Diagnosed on surgical biopsy |
Country | Name | City | State |
---|---|---|---|
Turkey | Ege University | Izmir |
Lead Sponsor | Collaborator |
---|---|
Ege University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | upgrade rates related to histologic subtype, tissue sampling and other variables | the results from excisional biopsy or at least 1 year follow-up documentation | one year |
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