CK19 Combined With Contrast-enhanced Ultrasound: a Prediction System on Axillary Lymph Node Metastasis in Breast Cancer

NCT02992067 | Completed Results DMC

• 1 other identifier: ZJCH-CK19A
• Study Type: observational
• Target: 359
• Locations: 1 country
• Sites: 1

Brief Summary

To establish a predicting system on axillary lymph node metastasis based on peripheral blood CK19mRNA and contrast-enhanced ultrasound.

Conditions

Lymph Node; Breastcancer

Keywords

lymph node metastasis; breast cancer; CK19; contrast-enhanced ultrasonography

Outcome Measures

Primary Outcomes (1)

• The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node

  The accuracy means the conformity of predicting results and the pathological result in lymph node involvement and also the false negative rate of sentinel lymph node (SLN) and non-SLN (nSLN) using prediction model by CK19 combined with CEUS examination

  1 year

Study Arms (1)

Operable breast cancer

clinical stage: cTis, cI, cII, cT3N1M0

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Operable breast cancer patients (clinical stage: cTis, cI, cII, cT3N1M0)

You may qualify if:

• female, age 18\~70 years old
• the test group should be in accordance with the pathological diagnosis of breast cancer, the clinical stage of breast cancer (stage cTis, cI, cII and cT3N1M0), the initial treatment to receive surgical treatment. Complete preoperative clinical diagnosis data, including the ipsilateral axillary lymph node CEUS data and peripheral blood sample; The negative-control group should comply with the pathological diagnosis, breast adenosis, fibrocystic lesions, breast cysts and other benign lesions, with complete preoperative clinical data, also including ipsilateral axillary lymph node CEUS data and peripheral blood sample

You may not qualify if:

• metastatic breast cancer, inflammatory breast disease, surgery without lymph node staging
• pregnancy or lactation
• patients with hematopoietic system disease or cancer, autoimmune diseases
• preservation of substandard peripheral blood samples.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

• Qiao E, Yu X, Zhou L, Wang C, Yang C, Yu Y, Chen D, Huang J, Yang H. A Prospective Validation Cohort Study of a Prediction Model on Non-sentinel Lymph Node Involvement in Early Breast Cancer. Ann Surg Oncol. 2020 May;27(5):1653-1658. doi: 10.1245/s10434-019-07980-x. Epub 2019 Oct 28.

  PMID: 31659631 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

Lymphatic Metastasis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Yu Xingfei
• Organization: Zhejiang Cancer Hospital

yuxf1177@zjcc.org.cn

057188122001

Study Officials

• Xingfei Yu, M.D.

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Breast Tumor Surgery (Department 104)

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 14, 2016
• Study Start: April 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 4, 2019
• Results First Posted: October 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)