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

NCT ID: NCT02992769

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Female

Keywords

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Breast Cancer Nomogram Ultrasound Axillary Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Fengyan Yu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fengyan Yu, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Locations

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Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianguo Lai, M.D.

Role: CONTACT

Phone: 0086-15622172952

Email: [email protected]

Facility Contacts

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Jianguo Lai, M.D

Role: primary

References

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Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

Reference Type BACKGROUND
PMID: 25651787 (View on PubMed)

Lyman GH, Temin S, Edge SB, Newman LA, Turner RR, Weaver DL, Benson AB 3rd, Bosserman LD, Burstein HJ, Cody H 3rd, Hayman J, Perkins CL, Podoloff DA, Giuliano AE; American Society of Clinical Oncology Clinical Practice. Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2014 May 1;32(13):1365-83. doi: 10.1200/JCO.2013.54.1177. Epub 2014 Mar 24.

Reference Type BACKGROUND
PMID: 24663048 (View on PubMed)

Bevilacqua JL, Kattan MW, Fey JV, Cody HS 3rd, Borgen PI, Van Zee KJ. Doctor, what are my chances of having a positive sentinel node? A validated nomogram for risk estimation. J Clin Oncol. 2007 Aug 20;25(24):3670-9. doi: 10.1200/JCO.2006.08.8013. Epub 2007 Jul 30.

Reference Type BACKGROUND
PMID: 17664461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22835916 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26779976 (View on PubMed)

Other Identifiers

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201653

Identifier Type: -

Identifier Source: org_study_id