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

NCT06591039 | Recruiting

• 1 other identifier: ATOSSA-001
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To construct a prospective, multi-center breast cancer treatment cohort in China, and analyze the factors affecting breast cancer diagnosis and treatment.
2. 2.To evaluate the diagnosis and treatment and prognosis of breast cancer among patients in different regions and hospitals.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

• The current status of patients diagnosed with breast cancer and their types of treatment

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

  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

  Including patient disease-free survival and 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

Secondary Outcomes (2)

• 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

• 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

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with malignant breast tumors

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer Hospital/ Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jiong Wu, M.D

  Cancer Hospital/ Institute, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiong Wu, M.D

CONTACT

+862164175590; wujiong1122@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2022
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)