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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03193008

Enrollment

1400

Registered

2017-06-20

Start date

2017-04-01

Completion date

2017-07-15

Last updated

2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Axillary ultrasound, Sentinel lymph node biopsy, Axillary management

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Detection of axillary tumor burden by axillary ultrasound	Two weeks after the axillary surgery	To calculate the negative predictive value of AUS/FNAC in those patients with breast cancer who meet ACOSOG Z0011 criteria.

Countries

Spain

Outcome results