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Clinical Trials/NCT04076111
NCT04076111
Not yet recruiting
Not Applicable

Patterns of Breast Cancer Management and Prognosis of Breast Cancer in China:a Multicenter, Prospective, Real-world Cohort Study

Fengxi Su5 sites in 1 country20,000 target enrollmentSeptember 5, 2019
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Fengxi Su
Enrollment
20000
Locations
5
Primary Endpoint
Breast-conserving surgery rate,
Status
Not yet recruiting
Last Updated
6 years ago

Overview

Brief Summary

This is a multicenter, prospective, e, real-world cohort survey initiated by researchers to focus on the patterns of breast cancer management and prognosis of breast cancer in China, and to establish the multicenter, prospective breast cancer data platform. A total of 18 sites in Guangdong and Henan have cooperated to build a cooperative network unit. The sites will conduct prospective and standardized records concerning the clinical pathological features, treatment and prognosis of the early breast cancer patients who are treated in their own site each year, registering in the REDCap system.This real-world cohort study aims to provide a representative and reliable survey data of epidemiological characteristics, clinical treatment and prognosis of patients with early breast cancer in China and explore the establishment of a national multi-center breast cancer data platform model.

Registry
clinicaltrials.gov
Start Date
September 5, 2019
End Date
December 2025
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fengxi Su
Responsible Party
Sponsor Investigator
Principal Investigator

Fengxi Su

PI

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

Eligibility Criteria

Inclusion Criteria

  • Patients who are hospitalized and treated in a collaborative network unit
  • Agree to enroll in the study and sign the informed consent form
  • Histological diagnosis of ductal carcinoma in situ or invasive breast cancer
  • Accept the Surgery-based surgical treatment
  • Willing to cooperate with follow-up work

Exclusion Criteria

  • Previously Excisional biopsy (including minimally invasive resection) of the patient's breast
  • Previously received neoadjuvant chemotherapy
  • Imaging or histological evidence of distant metastasis

Outcomes

Primary Outcomes

Breast-conserving surgery rate,

Time Frame: baseline

the proportion between breast-conserving surgery and breast mastectomy surgery baseline

Breast-conserving surgery rate, sentinel lymph node biopsy rate

Time Frame: baseline

the proportion between sentinel lymph node biopsy and axillary lymph node dissection

Secondary Outcomes

  • Disease free survival (DFS)(5year)
  • Overall survival (OS)(5year)
  • Epidemiological distribution of pathological stage of breast cancer(baseline)

Study Sites (5)

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