Plain English Summary
Background and study aims
Today, breast cancer is diagnosed at an early stage due to public screening mammography and increased awareness of the disease in the community. As a consequence of early diagnosis, tumor size at time of diagnosis has decreased and the risk of spread to the lymph nodes now affects less than 30% of all breast cancer patients. Despite this, all breast cancer patients undergo a surgical procedure, sentinel lymph node biopsy, to define if axillary lymph nodes are infiltrated by cancer cells. In more than 70% of these patients, there have no cancer infiltration in their axillary lymph nodes and therefore, the procedure has no benefit. Sentinel lymph node biopsy can lead to side-effects such as pain and swelling.
The aim of the study is to evaluate the capacity of patient related and tumor characteristics to determine whether the cancer has spread to the lymph nodes, so that low-risk groups can avoid sentinel node biopsy.
Who can participate?
Patients diagnosed with invasive breast cancer at any age scheduled for primary surgery and without clinically pathological lymph nodes
What does the study involve?
There is no direct involvement for participants. Instead, their medical records and data will be analysed by the study team and they will receive breast cancer treatment as usual.
What are the possible benefits and risks of participating?
As there is no direct involvement of participants and they will receive routine treatment, there are no known benefits or risks to participants taking part in this study.
Where is the study run from?
Skåne University Hospital (Lund and Malmö) (Sweden)
When is the study starting and how long is it expected to run for?
January 2008 to December 2018
Who is funding the study?
1. Lund Univerisity (Sweden)
2. The Swedish Breast Cancer Fund (Sweden)
3. South Swedish Health Care Region (Sweden)
4. Erling Persson Foundation (Sweden)
Who is the main contact?
Professor Lisa Rydén
lisa.ryden@med.lu.se
Trial website
Contact information
Type
Scientific
Primary contact
Prof Lisa Rydén
ORCID ID
http://orcid.org/0000-0001-7515-3130
Contact details
Lund University
Medicon Village
Scheleevägen 2
Lund
SE-22381
Sweden
+46-706720923
lisa.ryden@med.lu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NILS 1.0
Study information
Scientific title
NILS: Non-Invasive Lymph node Staging
Acronym
NILS
Study hypothesis
Preoperatively available information on clinicaopathological characteristics can aid in predicting nodal status in primary breast cancer
Ethics approval
Lund University, 15/08/2012, 2012/340
Study design
Observational prospective cohort study with retrospective estimation of nodal status
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Clinically node-negative primary breast cancer
Intervention
Patients in this study are undergoing standard diagnostic work-up within the clinical pathway for breast cancer including a clinical examination, mammogram, ultrasound and core biopsy of the tumor before surgery. At time of surgery, they undergo standard procedure according to the multidisciplinary conference and the tumor and axillary nodes are pathologically examined. No extra diagnostic or interventional procedure is undertaken. Logistic regression and artificial neural network models are applied to predict nodal status from clincopathological data. No follow-up data is extracted as this is an observational diagnostic trial.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Axillary nodal status stratified by stage N0, N1 and N2, determined from pre-operatively available clinicopathological data after surgery
Secondary outcome measures
False negative rate with negative predictive value of NPV max to 10% for prediction of N0, determined from sentinel node biopsy data after surgery
Overall trial start date
01/01/2008
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Invasive breast cancer
2. Clinically node-negative disease
3. Scheduled for primary surgery
4. Female
Participant type
Patient
Age group
All
Gender
Female
Target number of participants
800
Total final enrolment
800
Participant exclusion criteria
1. Male
2. Previous ipsilateral breast or axillary surgery
3. Previous neoadjuvant therapy
4. Palpable axillary lymphadenopathy
5. No axillary staging
Recruitment start date
01/01/2009
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Sweden
Trial participating centre
Skåne University Hospital
Lund and Malmö
22185
Sweden
Sponsor information
Organisation
Lund University
Sponsor details
Medicon Village 406
Scheleevägen 2
Lund
223 85
Sweden
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Lunds Universitet
Alternative name(s)
Lund University
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Sweden
Funder name
South Swedish Health Care Region
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bröstcancerfonden
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Familjen Erling Perssons Stiftelse
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
A nomogram based on logistic regression data has been published and external validation is ongoing. Data analysis from ANN is finished and a manuscript is pending
IPD sharing statement:
The datasets analysed during the current study will be available upon request from Lisa Rydén (lisa.ryden@med.lu.se) for baseline characteristics after approval from regulatory authorities responsible of data sharing for Region Skåne. The dataset is kept pseudoanonymised and will be available for any researcher with a documented scientific experience in prediction models of nodal status in order to validate other prediction models generated from their own data. GDPR requires an informed consent to state that data sharing with third party is to be performed and this can be arranged by an opt-out procedure.
Intention to publish date
31/03/2019
Participant level data
Available on request
Basic results (scientific)
See additional file (ISRCTN14341750_BasicResults_02Nov2018)
Publication list
1. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28718896
2. 2019 artificial neural network modeling results in https://www.ncbi.nlm.nih.gov/pubmed/31226956 (added 24/06/2019)
Publication citations
Additional files
- ISRCTN14341750_BasicResults_02Nov2018.pdf uploaded 24/04/2019