A Prospective Validation Cohort Study of a Prediction System on nSLN Metastasis in Early Breast Cancer

NCT03280134 | Unknown

• 1 other identifier: ZJCH-CK19B
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

Brief Summary

In the previous study, the investigator established a predictive model for non-sentinel lymph node involvement in early breast cancer (cT1-2cN0, 1-2 SLNs involvement). To validation the clinical value of the model, the investigator design a prospectively research using the model guiding for further axillary lymph node dissection in SLN-positve early breast cancer.

Conditions

Lymph Node Metastases; Breast Cancer; Predictive Cancer Model

Keywords

non-sentinel lymph node; breast cancer; prediction; CK19; contrast-enhanced ultrasound

Outcome Measures

Primary Outcomes (1)

• disease-free survival (DFS)

  The time from enrollment to the first recurrent or metastasis event

  3-year(mid-term) 5-year

Secondary Outcomes (2)

• local recurrent rate

  3-year(mid-term) 5-year

• overal survival (OS)

  3-year(mid-term) 5-year

Study Arms (2)

predictive nSLN-

NO INTERVENTION

No further axillary lymph node dissection (ALND)

predictive nSLN+

ACTIVE COMPARATOR

axillary lymph node dissection (ALND)

Procedure: axillary lymph node dissection (ALND)

Interventions

axillary lymph node dissection (ALND) PROCEDURE

If the patients had predictive nSLN+, need further axillary lymph node dissection.

predictive nSLN+

Eligibility Criteria

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

You may qualify if:

• 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

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

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

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

Study Officials

• XF YU, M.D.

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

XF YU, M.D.

CONTACT

+8657188122001; yuxf1177@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: This study based on prospective cohort method and concerning on the two groups (whether ALND or not) by predictive model nSLN results.

Study Record Dates

• First Submitted: September 9, 2017
• First Posted: September 12, 2017
• Study Start: October 15, 2018
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: June 4, 2019

Record last verified: 2019-06

Locations

CN (1)