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Recruiting NCT06591039

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

Observational Breast Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The study did not involve intervention in the patient's treatment regimen.
Who it may be relevant to
Registry conditions: Breast Neoplasms. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure The 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.

Primary outcome measures

  • The current status of patients diagnosed with breast cancer and their types of treatment [Time frame: 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]
  • Prognostic outcomes of patients [Time frame: 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]
Secondary outcome measures (2)
  • Prognosis-recurrence-free survival [Time frame: 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]
  • Prognosis-overall survival [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Cancer Hospital/ Institute, Fudan University — Shanghai

Identifiers

NCT: NCT06591039 · ATOSSA-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗