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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04076111
• Other study ID #: BCSCO003
• Status: Not yet recruiting
• Start date: September 5, 2019
• Est. completion date: December 2025

Study information

• Verified date: August 2019
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Min Peng
• Phone: 8613430344686
• Email: pengm33[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
China	Guangdong Province Hospital of Chinese Medicine	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital,Sun Yat-sen University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Cancer Hospital OF Shantou University Medical College	Shantou	Guangdong
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Fengxi Su

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast-conserving surgery rate,	the proportion between breast-conserving surgery and breast mastectomy surgery baseline	baseline
Primary	Breast-conserving surgery rate, sentinel lymph node biopsy rate	the proportion between sentinel lymph node biopsy and axillary lymph node dissection	baseline
Secondary	Epidemiological distribution of pathological stage of breast cancer	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
Secondary	Disease free survival (DFS)	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
Secondary	Overall survival (OS)	Overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.	5year