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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06591039
Enrollment
20000
Registered
2024-09-19
Start date
2022-07-01
Completion date
2025-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

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

Interventions

PROCEDUREThe study did not involve intervention in the patient's treatment regimen

This study is based on a prospective database platform to register the occurrence, treatment and prognosis of breast cancer in China, so there is no clear exposure factor. This study was a prospective cohort study, which did not intervene in exposure factors, but only assessed the occurrence, treatment, and prognosis of breast cancer in China.

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Prognosis-recurrence-free survivalFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsThe time from the diagnosis of breast cancer to the recurrence or metastasis of the patient, and the parts involved.
Prognosis-overall survivalFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsAs the time from diagnosis of breast cancer to death of the patient

Countries

China

Contacts

Primary ContactJiong Wu, M.D
wujiong1122@vip.sina.com+862164175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026