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Diagnosis of axillary lymph node status in primary breast cancer without a surgical procedure

NILS: Non-Invasive Lymph node Staging

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14341750
Enrollment
23400
Registered
2018-11-23
Start date
2009-01-01
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinically node-negative primary breast cancer Cancer Clinically node-negative primary malignant neoplasms of breast

Interventions

Current intervention as of 31/08/2021: Patients in this study are undergoing standard diagnostic work-up within the clinical pathway for breast cancer including a clinical examination, mammogram, ultr

Sponsors

Lund University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 31/08/2021: 1. Invasive breast cancer 2. Clinically and ultrasound node-negative disease 3. Scheduled for primary surgery 4. Female _____ Previous inclusion criteria: 1. Invasive breast cancer 2. Clinically node-negative disease 3. Scheduled for primary surgery 4. Female

Exclusion criteria

Exclusion criteria: 1. Male 2. Previous ipsilateral breast or axillary surgery 3. Previous neoadjuvant therapy 4. Palpable axillary lymphadenopathy 5. No axillary staging

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 31/08/2021: Axillary nodal status stratified by stage N0, N1 and N2, determined from pre-operatively available clinicopathological data after surgery compared with the predictive N-status by the algorithms _____ Previous primary outcome measure: Axillary nodal status stratified by stage N0, N1 and N2, determined from pre-operatively available clinicopathological data after surgery

Secondary

MeasureTime frame
False negative rate with negative predictive value of NPV max to 10% for prediction of N0, determined from sentinel node biopsy data after surgery

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026