Condition category
Cancer
Date applied
21/10/2018
Date assigned
23/11/2018
Last edited
23/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

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

www.med.lu.se

Funders

Funder type

University/education

Funder name

Lunds Universitet

Alternative name(s)

Lund University

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

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)

Publication list

2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28718896

Publication citations

Additional files

Editorial Notes