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

Not Applicable

Completed

• Conditions: Clinically node-negative primary breast cancer; Cancer; Clinically node-negative primary malignant neoplasms of breast

• Registration Number: ISRCTN14341750
• Lead Sponsor: und University

Brief Summary

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28718896 Nomogram initial results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31226956 Artificial neural network modeling initial results (added 24/06/2019) 2021 Other publications in https://doi.org/10.1093/bjsopen/zrab027 Nomogram validation (added 31/08/2021) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38229058/ Retrospective validation study (added 22/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-23
• Study Completion: 2022-12-21
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 23400

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
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Previous inclusion criteria:
1. Invasive breast cancer
2. Clinically node-negative disease
3. Scheduled for primary surgery
4. Female

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified