NCT02523612

Brief Summary

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:

  1. 1.The risk of underestimating the severity of the lesion biopsied currently leads systematically to achieve a surgical resection for these patients while a breast cancer (BC) will finally identified at surgery in 10 to 25% of cases. Thus, unnecessary surgeries will be performed in 75 to 90% of cases (no cancer).
  2. 2.These breast lesions confer long-term increase in the subsequent risk of breast cancer (cumulative incidence of 15 to 25% at 25 years). Thus, women identified with atypical lesions are then followed using clinical and mammographic annual evaluation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

3 years

First QC Date

August 6, 2015

Last Update Submit

July 20, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Exploratory research for biomarkers using DNA Seq

    Up to 3 months

Study Arms (1)

Patients with atypical lesions

EXPERIMENTAL
Procedure: BiopsyProcedure: Blood sample

Interventions

BiopsyPROCEDURE
Patients with atypical lesions
Blood samplePROCEDURE
Patients with atypical lesions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women who have had a recent diagnosis of atypical breast lesions (atypical metaplasia, atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ) on a breast biopsy for microcalcifications on mammography Or for little suspect distortion in ultrasound or mammary MRI.
  • Report of the anatomopathological examination of the biopsy allowing the diagnosis of an atypical lesion available
  • Patient 18 years or more
  • Informed consent signed.
  • Patient affiliated to a system of social security or beneficiary of such plan
  • General condition ECOG-OMS 0 or 1

You may not qualify if:

  • Nodular lesion associated with ultrasound or mammography opacity
  • Palpable nodule
  • Presence of ductal carcinoma in situ or invasive carcinoma associated to biopsy
  • Personal history of breast cancer or homo contralateral
  • Previous history of breast irradiation or breast cancer or other area for malignancy (Hodgkin, etc ...)
  • Women with a BRCA1 or BRCA2 mutation diagnosed or other genetic predisposition to breast cancer and highly penetrant autosomal dominant.
  • Pregnant or nursing women
  • Women with a cons-indication or refusal of surgery
  • Private Women of freedom under guardianship.
  • Presence of aggressive lobular in situ carcinoma (plĂ©ioforme, Florida or necrosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val De Marne, 94805, France

Location

Related Publications (1)

  • 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.

    PMID: 32920723DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BiopsyBlood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesPunctures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 14, 2015

Study Start

June 24, 2015

Primary Completion

June 25, 2018

Study Completion

June 25, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07

Locations

FR(1)