Clinical trial NCT04076111: Patterns of Breast Cancer Management and Prognosis of Breast Cancer in China
Official title: Patterns of Breast Cancer Management and Prognosis of Breast Cancer in China：a Multicenter, Prospective, Real-world Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had early stage breast cancer and completed breast surgery

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.


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

Primary outcomes:
measure: Breast-conserving surgery rate,
timeFrame: baseline
measure: Breast-conserving surgery rate, sentinel lymph node biopsy rate
timeFrame: baseline
Secondary outcomes:
measure: Epidemiological distribution of pathological stage of breast cancer
timeFrame: baseline
measure: Disease free survival (DFS)
timeFrame: 5year
measure: Overall survival (OS)
timeFrame: 5year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Shantou
country: China
facility: Cancer Hospital OF Shantou University Medical College
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Sun Yat-sen Menorial Hospital
name: Fengxi Su, MD
role: STUDY_CHAIR
affiliation: Sun Yat-sen Menorial Hospital
name: Qiang liu, MD
role: STUDY_CHAIR
affiliation: Sun Yat-sen University
name: Musheng Zeng, MD
role: STUDY_DIRECTOR
affiliation: Guuangdong Province Hospital of Chinese Medicine
name: Qianjun Chen, MD
role: STUDY_DIRECTOR
References: