An observational study in Premalignant Lesion, sponsored by Ege University. Completed at 1 site in Turkey. Open to female participants. Per ClinicalTrials.gov, last updated 2022-05-02.
Sponsored by Ege University · 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.
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.
254 studies on the registry are indexed under Precancerous Conditions; 28 are open to participants now.
This study's enrollment of 1,345 is above the median of 160 across 64 observational studies indexed under Precancerous Conditions.
Browse Precancerous Conditions studies →Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.
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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
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:
Exclusion Criteria:
upgrade rates related to histologic subtype, tissue sampling and other variables
the results from excisional biopsy or at least 1 year follow-up documentation
Time frame: one year
Plan to share: Yes — After finishing statistical analysis the results will be published
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Ege University