Breast CancerNCT02197949
Preoperative and Intraoperative Quantification of Axillary Tumoral Load
An observational study of Breast Cancer, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
At present, patients diagnosed of a breast cancer with infiltration of the axillary lymph-nodes are submitted to axillary lymph-node dissection (ALND). The sentinel node (SN) technique is not indicated when a lymph-node biopsy or cytology is positive, nor when the surgical treatment is upfront neither when a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2014to Mar 2016
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer
Who may be able to join
- Breast cancer patients with infiltrated axillary lymph nodes cT1-4 cN1
- Older than 18 years old
- Able to understand and accept the protocol procedure and to sign an informed consent form in accordance with national legislation.
Who cannot join
- Breast cancer patients in whom no information about axillary lymph nodes status (cytology or biopsy) is available.
- Patients younger than 18 years old.
- Psychiatric disease
- Difficulties to understand Spanish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative and Intraoperative Quantification of Axillary Tumoral Load to Reduce the Need of Axillary Lymph Node Dissection in Breast Cancer Patients With Positive Lymph-nodes at Diagnosis
At present, patients diagnosed of a breast cancer with infiltration of the axillary lymph-nodes are submitted to axillary lymph-node dissection (ALND). The sentinel node (SN) technique is not indicated when a lymph-node biopsy or cytology is positive, nor when the surgical treatment is upfront neither when a neoadjuvant systemic therapy is indicated. The reason for not performing SN is that patients diagnosed of an infiltrated axilla though ultrasound-guided biopsy or cytology tend to have a higher tumoral load than those diagnosed after a sentinel biopsy. Furthermore, even if these patients are submitted to a neoadjuvant systemic treatment and the axillary clinical exploration is negative after the treatment, different studies showed that the SN false negative rate is unacceptably high.
Despite these facts, a high proportion of patients with a positive axilla at diagnosis and submitted to level I and II axillary lymph node dissection show few lymph nodes infiltrated in the pathological study, frequently four or less neoplastic nodes. New methods of detecting these patients with limited infiltrated nodes should be developed and new approaches to axillary surgery (i.e., partial resection) should be offered.
Read more
To date, the only information expected to get after an axillary imaging is performed is if the axilla is infiltrated or not. No information about the tumoral load is demanded. In the other hand, level I and II ALND is performed according to established anatomic limits, without selecting the nodes to be excised neither identifying the ones infiltrated for a directed excision.
The aim of the study is to evaluate the ability of a specified and reproducible imaging protocol for distinguishing patients with a high axillary tumoral load from the ones with a low tumoral load. At the same time, as the initial nodes receiving lymph drainage should be the ones commonly affected, identifying these nodes injecting diluted methylene blue in the retroareolar parenchyma and studying their tumoral load could help selecting patients with high from those with low axillary tumoral load.
Evaluation of both steps (that is, first the imaging protocol followed by the methylene blue protocol), could eventually help to distinguish which patients should be submitted to a classical level I and II ALND and which ones can be spared from excising the lymph nodes not stained by the methylene blue.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients with infiltrated axillary l | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axillary tumoral load
-Accuracy to detect patients with low axillary tumoral load (in terms of sensibility and specificity) of a protocol including systematic a reproducible axillary imaging and identification of the first axillary nodes through methylene blue retroareolar injection.
Measured: During surgery (one evaluation)
Secondary outcomes (1)
Methylene blue injection to identify nodes of the lymphatic drainage.
-Identification of clinical data influencing accuracy of methylene blue injection to identify the first four to six lymph nodes of the lymphatic drainage.
Measured: During surgery (one evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Slow recuitment
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria del Mar Vernet, Parc de Salut Mar
- Investigators
- Maria del Mar Vernet, MD, PhD, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197949
- Sponsor's protocol ID
- ELISA
- Status last verified
- Nov 2016
- First submitted
- 18 Jul 2014
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative and Intraoperative Quantification of Axillary Tumoral Load to Reduce the Need of Axillary Lymph Node Dissection in Breast Cancer Patients With Positive Lymph-nodes at Diagnosis
- ClinicalTrials.gov ID
- NCT02197949
- Acronym / sponsor ID
- ELISA
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow recuitment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Jul 2014 (estimated)
- 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.
At present, patients diagnosed of a breast cancer with infiltration of the axillary lymph-nodes are submitted to axillary lymph-node dissection (ALND). The sentinel node (SN) technique is not indicated when a lymph-node biopsy or cytology is positive, nor when the surgical treatment is upfront neither when a neoadjuvant systemic therapy is indicated. The reason for not performing SN is that patients diagnosed of an infiltrated axilla though ultrasound-guided biopsy or cytology tend to have a higher tumoral load than those diagnosed after a sentinel biopsy. Furthermore, even if these patients are submitted to a neoadjuvant systemic treatment and the axillary clinical exploration is negative after the treatment, different studies showed that the SN false negative rate is unacceptably high.
Despite these facts, a high proportion of patients with a positive axilla at diagnosis and submitted to level I and II axillary lymph node dissection show few lymph nodes infiltrated in the pathological study, frequently four or less neoplastic nodes. New methods of detecting these patients with limited infiltrated nodes should be developed and new approaches to axillary surgery (i.e., partial resection) should be offered.
To date, the only information expected to get after an axillary imaging is performed is if the axilla is infiltrated or not. No information about the tumoral load is demanded. In the other hand, level I and II ALND is performed according to established anatomic limits, without selecting the nodes to be excised neither identifying the ones infiltrated for a directed excision.
The aim of the study is to evaluate the ability of a specified and reproducible imaging protocol for distinguishing patients with a high axillary tumoral load from the ones with a low tumoral load. At the same time, as the initial nodes receiving lymph drainage should be the ones commonly affected, identifying these nodes injecting diluted methylene blue in the retroareolar parenchyma and studying their tumoral load could help selecting patients with high from those with low axillary tumoral load.
Evaluation of both steps (that is, first the imaging protocol followed by the methylene blue protocol), could eventually help to distinguish which patients should be submitted to a classical level I and II ALND and which ones can be spared from excising the lymph nodes not stained by the methylene blue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients with infiltrated axillary l | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer
Key inclusion criteria (3 listed)
- Breast cancer patients with infiltrated axillary lymph nodes cT1-4 cN1
- Older than 18 years old
- Able to understand and accept the protocol procedure and to sign an informed consent form in accordance with national legislation.
Key exclusion criteria (4 listed)
- Breast cancer patients in whom no information about axillary lymph nodes status (cytology or biopsy) is available.
- Patients younger than 18 years old.
- Psychiatric disease
- Difficulties to understand Spanish.
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
Axillary tumoral load
Time frame: During surgery (one evaluation)
-Accuracy to detect patients with low axillary tumoral load (in terms of sensibility and specificity) of a protocol including systematic a reproducible axillary imaging and identification of the first axillary nodes through methylene blue retroareolar injection.
1 secondary outcome
Methylene blue injection to identify nodes of the lymphatic drainage.
Time frame: During surgery (one evaluation)
Results and safety
The study was stopped early (reason given: Slow recuitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- 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.
Maria del Mar Vernet, MD, PhD principal investigator
Parc de Salut Mar
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 Parc de Salut Mar 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Nov 2016. 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?
The study was stopped early (reason given: Slow recuitment). 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?
Axillary tumoral load (time frame: During surgery (one evaluation)). 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 8 Nov 2016.