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

NCT04076111 | Unknown

• 1 other identifier: BCSCO003
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Breast-conserving surgery rate,

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

  baseline

• Breast-conserving surgery rate, sentinel lymph node biopsy rate

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

  baseline

Secondary Outcomes (3)

• Epidemiological distribution of pathological stage of breast cancer

  baseline

• Disease free survival (DFS)

  5year

• Overall survival (OS)

  5year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had early stage breast cancer and completed breast surgery

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fengxi Su: lead

Study Sites (5)

Guangdong Province Hospital of Chinese Medicine

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Cancer Hospital OF Shantou University Medical College

Shantou, Guangdong, 515000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fengxi Su, MD

  Sun Yat-sen Menorial Hospital

  STUDY CHAIR

• Qiang liu, MD

  Sun Yat-sen Menorial Hospital

  STUDY CHAIR

• Musheng Zeng, MD

  Sun Yat-sen University

  STUDY DIRECTOR

• Qianjun Chen, MD

  Guuangdong Province Hospital of Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Min Peng

CONTACT

8613430344686; pengm33@mail.sysu.edu.cn

Kai Chen, MD

CONTACT

8615920164730; chenkai23@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: August 25, 2019
• First Posted: September 3, 2019
• Study Start: September 5, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 3, 2019

Record last verified: 2019-08

Locations

CN (5)