Breast CancerNCT03193008
Current Value of Axillary Ultrasound in the Staging of Breast Cancer. Is BSGC Still Necessary?
An observational study of Breast Cancer, run by Corporacion Parc Tauli at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1,400 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2017to 15 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically confirmed breast cancer from January 2008 to December 2013
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Axillary ultrasound, Sentinel lymph node biopsy, Axillary management
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks after the axillary surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start1 Apr 2017
- Primary completion15 Jul 2017 (estimated)
- Study completion15 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier del Riego, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193008
- Sponsor's protocol ID
- CPT-JDR-2017-1
- Status last verified
- Jun 2017
- First submitted
- 28 Apr 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Value of Axillary Ultrasound in the Staging of Breast Cancer. Is BSGC Still Necessary?
- ClinicalTrials.gov ID
- NCT03193008
- Acronym / sponsor ID
- CPT-JDR-2017-1
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Axillary ultrasound, Sentinel lymph node biopsy, Axillary management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 15 Jul 2017 (estimated)
- Study completion
- 15 Jul 2017 (estimated)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed breast cancer from January 2008 to December 2013
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of axillary tumor burden by axillary ultrasound (time frame: Two weeks after the axillary surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.