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

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT04076111
• Lead Sponsor: Fengxi Su

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-25
• Study First Submitted QC: 2019-08-29
• Last Update Submitted: 2019-08-29
• Study First Posted: 2019-09-03
• Last Update Posted: 2019-09-03
• Study Start: 2019-09-05
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breast-conserving surgery rate,	baseline	the proportion between breast-conserving surgery and breast mastectomy surgery baseline
Breast-conserving surgery rate, sentinel lymph node biopsy rate	baseline	the proportion between sentinel lymph node biopsy and axillary lymph node dissection

Secondary Outcome Measures

Name	Time	Method
Disease free survival (DFS)	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.
Overall survival (OS)	5year	Overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.
Epidemiological distribution of pathological stage of breast cancer	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

Trial Locations

Locations (5)

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, China