SMMaC trial: a prospective validation study of Sentinel lymph node biopsy in patients with Multicentric Mamma Carcinoma.

SMMaC trial: a prospective validation study of Sentinel lymph node biopsy in patients with Multicentric Mamma Carcinoma. - SMMaC trial: SLN biopsy in Multicentric Mamma Carcinoma.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35626

Enrollment

Registered

2008-01-23

Start date

2008-01-01

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

borst diagnostische verrichtingen at least 2 malignant breast tumors at multiple sites in one breast

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - patients with a preoperative diagnosis of multicentric infiltrating breast carcinoma - at least 2 positive lesions - clinically node negative (cN0) breast carcinoma - also T2-T3 cancers

Exclusion criteria

Exclusion criteria: - ductal or lobular in situ carcinomas - clinical and/or echographic evidence of positive axilla - neoadjuvant chemotherapy - previous ipsilateral breast or axillary surgery - preoperative radiotherapy - distant metastases - pregnant women

Design outcomes

Primary

Measure	Time frame
- successful identification of sentinel lymph nodes - mean number of excised sentinel lymph nodes - number of true positive sentinel lymph nodes - number of positive non-sentinel lymph nodes at axillary lymph node dissection o False negative rate= number of false negative SNs/ true positive+ false negative nodes x 100. o Sensitivity= true positive/ true positive + false negative x 100 o Negative predictive value= true negative / true negative + false negative x 100 o Accuracy= true positive + true negative/ successful SNBs x 100. o Likelihood ratio for negative test results=m(1- sensitivity)/ specificity	—

Measure

Time frame

- successful identification of sentinel lymph nodes - mean number of excised sentinel lymph nodes - number of true positive sentinel lymph nodes - number of positive non-sentinel lymph nodes at axillary lymph node dissection o False negative rate= number of false negative SNs/ true positive+ false negative nodes x 100. o Sensitivity= true positive/ true positive + false negative x 100 o Negative predictive value= true negative / true negative + false negative x 100 o Accuracy= true positive + true negative/ successful SNBs x 100. o Likelihood ratio for negative test results=m(1- sensitivity)/ specificity

—

Secondary

Measure	Time frame
None	—

Countries

Netherlands

Outcome results