Clinical trial NCT02992769: Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound
Official title: A Nomogram to Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Female
Keywords: Breast Cancer
Nomogram
Ultrasound
Axillary Metastases
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 Years to 70 Years (Adult)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Axillary Metastases
timeFrame: 4 months to 1.5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Fengyan Yu, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Gentilini O, Veronesi U. Abandoning sentinel lymph node biopsy in early breast cancer? A new trial in progress at the European Institute of Oncology of Milan (SOUND: Sentinel node vs Observation after axillary UltraSouND). Breast. 2012 Oct;21(5):678-81. doi: 10.1016/j.breast.2012.06.013. Epub 2012 Jul 25.
citation: Tucker NS, Cyr AE, Ademuyiwa FO, Tabchy A, George K, Sharma PK, Jin LX, Sanati S, Aft R, Gao F, Margenthaler JA, Gillanders WE. Axillary Ultrasound Accurately Excludes Clinically Significant Lymph Node Disease in Patients With Early Stage Breast Cancer. Ann Surg. 2016 Dec;264(6):1098-1102. doi: 10.1097/SLA.0000000000001549.