Current Value of Axillary Ultrasound in the Staging of Breast Cancer. Is BSGC Still Necessary?

NCT ID: NCT03193008

Last Updated: 2017-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-07-15

Brief Summary

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AUS/FNAC allows the identification of tumors without axillary tumor involvement, or with low axillary tumor burden, many of which do not benefit from SLNB, in the staging of early breast cancer.

Objective: To calculate the negative predictive value of AUS/FNAC in those patients with breast cancer who meet ACOSOG Z0011 criteria.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Tumors with ACOSOG Z0011 criteria, except positive SLNB (cT1-T2; cN0; breast-conserving surgery; Whole-Breast Radiotherapy)
* Axillary study with AUS/FNAC.
* SLNB/ALND (Gold-Standard).

Exclusion Criteria

* Tumors without confirmation of axillary histologic status (No Gold-Standard)
* Tumor in pregnancy or breastfeeding.
* Tumors in the male.
* Tumors treated with neoadjuvant chemotherapy
* Tumors that do not meet ACOSOG Z0011 criteria.
* Tumors without axillary study using AUS/FNAC
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Javier del Riego

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Javier del Riego

Sabadell, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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CPT-JDR-2017-1

Identifier Type: -

Identifier Source: org_study_id

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