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NCT Number: NCT06591039

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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 outcomes

  1. 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

    Including but not limited to the patient receiving different surgical methods, different drugs, neoadjuvant and adjuvant therapy, etc.

  2. 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

    Including patient disease-free survival and overall survival.

Secondary outcomes

  1. 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

    The time from the diagnosis of breast cancer to the recurrence or metastasis of the patient, and the parts involved.

  2. 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

    As the time from diagnosis of breast cancer to death of the patient

Study contacts

Contact information is provided by the study sponsor or research team.

Jiong Wu, M.D

CONTACT

[email protected]

+862164175590 ext. 88607

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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