Breast Cancer Clinical Trial
Official title:
Current Value of Axillary Ultrasound in the Staging of Breast Cancer. Is BSGC Still Necessary?
Verified date | June 2017 |
Source | Corporacion Parc Tauli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Javier del Riego | Sabadell | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Corporacion Parc Tauli |
Spain,
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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