A Multicenter Prospective Observational Cohort Based on a Breast Cancer Medical Record Database in China

Recruiting

• Conditions: Breast Neoplasms

• Registration Number: NCT06591039
• Lead Sponsor: Fudan University

Brief Summary

1. To construct a prospective, multi-center breast cancer treatment cohort in China, and analyze the factors affecting breast cancer diagnosis and treatment.

2. To evaluate the diagnosis and treatment and prognosis of breast cancer among patients in different regions and hospitals.

Detailed Description

This research aims to:

A. Understand and analyze the current status of breast cancer diagnosis and treatment; B. Publish an annual report on diagnosis and treatment; C. Data sharing, dynamic evaluation; D. Evaluate consensus and guideline promotion and implementation effects; E. Propose and set clinical quality standards for industry associations, and propose improvement goals; F. Provide a basis for industry associations to formulate specialized training programs; G. To provide assistance in the formulation of health insurance policies; H. Provide a platform for clinical research on breast cancer; I. Provide evidence for the formulation of clinical guidelines and consensus

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-08
• Last Update Submitted: 2024-09-08
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

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

Inclusion Criteria

• Patients with malignant breast tumors must be diagnosed by cytology or histology, and their pathological types include but are not limited to breast carcinoma in situ, invasive carcinoma, and breast sarcoma.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The current status of patients diagnosed with breast cancer and their types of treatment	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months	Including but not limited to the patient receiving different surgical methods, different drugs, neoadjuvant and adjuvant therapy, etc.
Prognostic outcomes of patients	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months	Including patient disease-free survival and overall survival.

Secondary Outcome Measures

Name	Time	Method
Prognosis-recurrence-free survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months	The time from the diagnosis of breast cancer to the recurrence or metastasis of the patient, and the parts involved.
Prognosis-overall survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months	As the time from diagnosis of breast cancer to death of the patient

Trial Locations

Locations (1)

Cancer Hospital/ Institute, Fudan University; 🇨🇳 Shanghai, Shanghai, China