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NCT03193008 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03193008
Other study ID # CPT-JDR-2017-1
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 28, 2017
Last updated June 19, 2017
Start date April 1, 2017
Est. completion date July 15, 2017

Study information
Verified date June 2017
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1400
Est. completion date July 15, 2017
Est. primary completion date July 15, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Javier del Riego Sabadell Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

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