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| ID | Type | Description | Link |
|---|---|---|---|
| 2015/2211 | Other Identifier | CSET number |
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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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Routine screening mammography has increased the non-palpable suspicious lesion detection rate, requiring histopathological evaluation. The discovery of atypical lesions on the breast biopsy is associated with two interrelated risks:
The goal would be to get a model to assess the risk and no longer operate those patients at high risk of BC. Several groups have attempted to identify predictors of concurrent or secondary BC associated with the discovery of an unusual lesion at biopsy. However, they are often focused on a subtype of atypia (eg atypical metaplasia, atypical ductal hyperplasia, atypical lobular hyperplasia) and no prediction model has been validated in prospective multicenter. Based on a large retrospective study at Gustave Roussy, a prediction model (Nomat) has been developed, common to all atypical lesions, which can predict the presence of a BC at excision surgery (risk of concurrent BC). This model is based on the age of the patient, the disappearance of radiographic abnormalities (microcalcifications in general) after the biopsy and initial radiological lesion size. This model has good performance with an area under the curve (AUC) of 0.72. In previous series, with a BC high-risk threshold of 20%, negative predictive value was 90%, and this model would have prevented the surgery in 51% of patients (low risk patients by model). It is essential to validate this model by forward-looking and in different centers to ensure its relevance.
This is a multicenter prospective validation of the model on 300 patients operated for atypical lesions in 21 centers. All patients with atypical breast lesions have a routine surgery. The clinical data, imaging and histological data will be collected prospectively. The main objective of this study is to validate the model Nomat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with atypical lesions | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Procedure |
| ||
| Blood sample |
| Measure | Description | Time Frame |
|---|---|---|
| Negative Predictive value of the NOMAT model | The primary endpoint is the negative predictive value (NPV) of Nomat model used to predict the absence of breast cancer associated with cases of atypical lesions in breast biopsy | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory research for biomarkers using DNA Seq | The study will be Nomat parallel homogeneous database of prospective clinical and pathological data of patients operated for atypical breast lesions associated with tissue and blood samples (5 mL in EDTA tube). This bank will exploratory research of new biomarkers and validation of new biomarkers that may emerge in the coming years. | Up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy Cancer Campus Grand Paris | Villejuif | Val De Marne | 94805 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32920723 | Derived | Uzan C, Mazouni C, Rossoni C, De Korvin B, de Lara CT, Cohen M, Chabbert N, Zilberman S, Boussion V, Vincent Salomon A, Espie M, Coutant C, Marchal F, Salviat F, Boulanger L, Doutriaux-Dumoulin I, Jouve E, Mathelin C, de Saint Hilaire P, Mollard J, Balleyguier C, Joyon N, Triki ML, Delaloge S, Michiels S. Prospective Multicenter Study Validate a Prediction Model for Surgery Uptake Among Women with Atypical Breast Lesions. Ann Surg Oncol. 2021 Apr;28(4):2138-2145. doi: 10.1245/s10434-020-09107-z. Epub 2020 Sep 12. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| D017437 |
| Skin and Connective Tissue Diseases |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D011677 | Punctures |