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

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ClinicalTrials.gov Identifier: NCT03193008
Recruitment Status : Unknown
Verified June 2017 by Javier del Riego, Corporacion Parc Tauli.
Recruitment status was:  Active, not recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Javier del Riego, Corporacion Parc Tauli

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.


Condition or disease
Breast Cancer

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Study Type : Observational
Estimated Enrollment : 1400 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Current Value of Axillary Ultrasound in the Staging of Breast Cancer. Is BSGC Still Necessary?
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : July 15, 2017
Estimated Study Completion Date : July 15, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Detection of axillary tumor burden by axillary ultrasound [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with histologically confirmed breast cancer from January 2008 to December 2013
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193008


Locations
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Spain
Javier del Riego
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli

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Responsible Party: Javier del Riego, MD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT03193008     History of Changes
Other Study ID Numbers: CPT-JDR-2017-1
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Javier del Riego, Corporacion Parc Tauli:
Breast Cancer
Axillary ultrasound
Sentinel lymph node biopsy
Axillary management

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases