Breast CancerSOLO-1NCT01669265
Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer
An observational study of Breast Cancer, run by SOLTI Breast Cancer Research Group at 9 sites in Spain.
Trial summary
This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 701 participants
- Where
- 9 sitesSpain
- Study dates
- Jun 2012to Aug 2012
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cT1-3, N0 breast cancer, who had intraoperative SLN evaluation by OSNA assay with a complete axillary lymph node dissection.
Who may be able to join
- Pathologically confirmed invasive breast carcinoma
- Stage T1-3,N0 evaluated by physical exam or imaging according to AJCC v.7 and best clinical local practices
- Intraoperative evaluation of sentinel lymph node (SLN) by OSNA
- Complete dissection of axillary lymph nodes after the evaluation of the SLNs by OSNA
- Pathology report of the tumor and dissected lymph nodes that includes the following information:
- primary tumor size (mm), tumor grade (Scarff-Bloom Richardson), estrogen receptor status
Show all 13Show fewer
- progesterone receptor status
- HER2 status (ASCO/CAP guidelines)
- Ki67 index
- presence/absence of lymphovascular invasion
- total number of sentinel and non-sentinel lymph nodes dissected during surgery
- total number of positive and negative sentinel and non-sentinel lymph nodes, *size of the metastasis in both sentinel and non-sentinel lymph nodes
- total tumoral load in each sentinel lymph node, expressed as number of CK19 mRNA copies per microliter.
Who cannot join
- Patients who underwent neoadjuvant chemotherapy
- CK19-negative breast tumor
- ALND with <10 lymph nodes
- In situ carcinoma only
- Metastatic breast cancer at time of diagnosis
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Hospital Clínico Universitario de Santiago de Compostela
A Coruña
Hospital Universitario de Bellvitge
Barcelona
Vall d´Hebron University Hospital
Barcelona
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas
Hospital Universitario Arnau de Vilanova
Lleida
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario de Salamanca
Salamanca
Hospital Universitario Virgen Del Rocio
Seville
Instituto Valenciano de Oncología
Valencia
About this study
This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.
The aim of the present study is to assess the intraoperative positive SLN total tumor load (TTL) obtained from the OSNA assay and to determine whether this TTL predicts non-SLN metastasis in patients with clinically node-negative early-stage breast cancer.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, OSNA, sentinel lymph node
- 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 |
|---|---|---|
| OSNA | Patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the negative predictive value of the technique OSNA.
Estimate the negative predictive value of the technique OSNA for the cutoff point that maximizes (tentatively, 10,000 to 15,000 copies / uL) of axillary lymph node involvement in breast cancer early N0.
Measured: At time of surgery
Secondary outcomes (5)
ROC curve that describes the assay
ROC curve (Receiver Operating Characteristic) from the true and false positives and negatives of OSNA test for different cutoffs
Measured: At time of surgery
Sensitivity of the assay
Probability that OSNA in sentinel lymph nodes (SLN) is positive given that there is involvement of non-sentinel lymph nodes (NSLN)
Measured: At time of surgery
Specificity of the assay
Probability that OSNA in SLN is negative because there is no involvement of NSLN
Measured: At time of surgery
Likelihood ratio for the cutoff of 10,000-15,000 copies/uL
Likelihood ratio of positive and negative results
Measured: At time of surgery
Positive predictive value at the cutoff of 10.000-15.000 copies/μL.
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 701 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOLTI Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Sysmex America, Inc.
- Responsible party
- Sponsor
- Investigators
- Vicente Peg, MD, Principal investigator, Vall d´Hebron University HospitalIsabel Rubio, MD, PhD, Study chair, Vall d´Hebron University HospitalMartin Espinosa-Bravo, MD, PhD, Study chair, Vall d´Hebron University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669265
- Sponsor's protocol ID
- SOLTI-1113
- Acronym
- SOLO-1
- Status last verified
- Nov 2014
- First submitted
- 24 May 2012
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Peg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antunez JR, de Salas MS, Delgado-Sanchez JJ, Pinto W, Gozalbo F, Petit A, Sansano I, Del Mar Tellez M, Rubio IT. Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients. Breast Cancer Res Treat. 2013 May;139(1):87-93. doi: 10.1007/s10549-013-2524-z. Epub 2013 Apr 11.
PubMed 23576079Peg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antúnez JJ, Salas MS, Sansano I, Delgado Sánchez JJ, Pinto W, Gozalbo F, Petit A, Rubio I. Intraoperative molecular analysis of sentinel lymph node as a new predictor of axillary status in early breast cancer. Poster session presented at: 35th Annual San Antonio Breast Cancer Symposium (SABCS); 2012 December 4th-8th; San Antonio, Texas, United States.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer
- ClinicalTrials.gov ID
- NCT01669265
- Acronym / sponsor ID
- SOLO-1 / SOLTI-1113
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, OSNA, sentinel lymph node
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- SOLTI Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Sysmex America, Inc.
- Study start
- Jun 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Aug 2012 (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.
This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.
The aim of the present study is to assess the intraoperative positive SLN total tumor load (TTL) obtained from the OSNA assay and to determine whether this TTL predicts non-SLN metastasis in patients with clinically node-negative early-stage breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSNA | – | –Patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cT1-3, N0 breast cancer, who had intraoperative SLN evaluation by OSNA assay with a complete axillary lymph node dissection.
Key inclusion criteria (13 listed)
- Pathologically confirmed invasive breast carcinoma
- Stage T1-3,N0 evaluated by physical exam or imaging according to AJCC v.7 and best clinical local practices
- Intraoperative evaluation of sentinel lymph node (SLN) by OSNA
- Complete dissection of axillary lymph nodes after the evaluation of the SLNs by OSNA
- Pathology report of the tumor and dissected lymph nodes that includes the following information:
Key exclusion criteria (5 listed)
- Patients who underwent neoadjuvant chemotherapy
- CK19-negative breast tumor
- ALND with <10 lymph nodes
- In situ carcinoma only
- Metastatic breast cancer at time of diagnosis
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
Estimate the negative predictive value of the technique OSNA.
Time frame: At time of surgery
Estimate the negative predictive value of the technique OSNA for the cutoff point that maximizes (tentatively, 10,000 to 15,000 copies / uL) of axillary lymph node involvement in breast cancer early N0.
5 secondary outcomes
ROC curve that describes the assay
Time frame: At time of surgery
Sensitivity of the assay
Time frame: At time of surgery
Specificity of the assay
Time frame: At time of surgery
Likelihood ratio for the cutoff of 10,000-15,000 copies/uL
Time frame: At time of surgery
Positive predictive value at the cutoff of 10.000-15.000 copies/μL.
Time frame: At time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
- Results publication: PubMed 23576079Peg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antunez JR, de Salas MS, Delgado-Sanchez JJ, Pinto W, Gozalbo F, Petit A, Sansano I, Del Mar Tellez M, Rubio IT. Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients. Breast Cancer Res Treat. 2013 May;139(1):87-93. doi: 10.1007/s10549-013-2524-z. Epub 2013 Apr 11.
- Results publicationPeg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antúnez JJ, Salas MS, Sansano I, Delgado Sánchez JJ, Pinto W, Gozalbo F, Petit A, Rubio I. Intraoperative molecular analysis of sentinel lymph node as a new predictor of axillary status in early breast cancer. Poster session presented at: 35th Annual San Antonio Breast Cancer Symposium (SABCS); 2012 December 4th-8th; San Antonio, Texas, United States.
- SOLTI Breast Cancer Research GroupLink provided by the sponsor.
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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.
Vicente Peg, MD principal investigator
Vall d´Hebron University Hospital
Isabel Rubio, MD, PhD study chair
Vall d´Hebron University Hospital
Martin Espinosa-Bravo, MD, PhD study chair
Vall d´Hebron University Hospital
9 sites 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 SOLTI Breast Cancer Research Group at 9 sites 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 13 inclusion and 5 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: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Estimate the negative predictive value of the technique OSNA. (time frame: At time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01669265, which also lists 2 linked publications.
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 18 Nov 2014.