Patterns of Breast Cancer Management and Prognosis of Breast Cancer in China

August 29, 2019 updated by: Fengxi Su

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen Memorial Hospital,Sun Yat-sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Erwei Song, MD
      • Guangzhou, Guangdong, China, 510000
        • Guangdong Province Hospital of Chinese Medicine
        • Contact:
      • Shantou, Guangdong, China, 515000
        • Cancer Hospital of Shantou University Medical College
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who had early stage breast cancer and completed breast surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast-conserving surgery rate,
Time Frame: baseline
the proportion between breast-conserving surgery and breast mastectomy surgery baseline
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
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiological distribution of pathological stage of breast cancer
Time Frame: baseline
the American Joint Committee on Cancer(AJCC) cancer staging system is used to assign stage for breast cancer patients,including primary tumor stage, regional nodes stage and metastasis stage
baseline
Disease free survival (DFS)
Time Frame: 5year
Disease free survival (DFS), which defined as the time from the diagnosis of breast cancer to the confirmed time of metastatic disease, or death due to any other cause.
5year
Overall survival (OS)
Time Frame: 5year
Overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.
5year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fengxi Su

Investigators

  • Study Chair: Fengxi Su, MD, Sun Yat-sen Menorial Hospital
  • Study Chair: Qiang liu, MD, Sun Yat-sen Menorial Hospital
  • Study Director: Musheng Zeng, MD, Sun Yat-sen University
  • Study Director: Qianjun Chen, MD, Guuangdong Province Hospital of Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 5, 2019

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

August 25, 2019

First Submitted That Met QC Criteria

August 29, 2019

First Posted (Actual)

September 3, 2019

Study Record Updates

Last Update Posted (Actual)

September 3, 2019

Last Update Submitted That Met QC Criteria

August 29, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCSCO003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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