Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound

A Nomogram to Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02992769

Enrollment

120

Registered

2016-12-14

Start date

2016-03-31

Completion date

2017-09-30

Last updated

2016-12-16

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

Conditions

Breast Cancer Female

Keywords

Breast Cancer, Nomogram, Ultrasound, Axillary Metastases

Brief summary

Axillary lymph node status is a vital prognostic factors in breast cancer patients and provides crucial information for making treatment decisions.This projective observational study is planned to identify risk factors for axillary metastases in breast cancer patients with axillary ultrasound and to construct a nomogram to predict the risk of axillary metastases in these patients.

Detailed description

Breast carcinoma is the most common malignancy in women, accounting for 25% of all female cancer cases and 15% of all cancer-related deaths in the world.Lymph node metastasis is a multifactorial event. Among patients with a preoperative axillary ultrasound, almost 40% of patients are pathologically proved to be free from axillary metastasis.The purpose of this study is to develop a nomogram to evaluate the probability of axillary metastasis as a tool to support clinical decision-making.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* female patients with primary breast cancer * receiving a successful SLNB or ALND * pathological diagnosed, without distant metastasis * a clinically negative axilla

Exclusion criteria

* pregnancy * neoadjuvant therapy * previous ipsilateral axillary surgery * inflammatory breast cancer

Design outcomes

Primary

Measure	Time frame	Description
Axillary Metastases	4 months to 1.5 year	Surgical treatment for breast cancer patients include breast-conserving surgery or mastectomy with or without breast reconstruction. Intraoperative ALND is carried out when the SLNs are positive by intraoperative frozen section. Post-operative H&E permanent staining is administered to confirm the results of the frozen section. Serial H&E and immunohistochemistry stain (IHC) are only carried out when axillary metastases are not visible after H&E staining.

Countries

China

Contacts

Primary ContactJianguo Lai, M.D.

clarkdawson0210@gmail.com0086-15622172952

Outcome results