Prospective Research for Elderly (≥65 Years Old) Early Breast Cancer Patients (EEBC)

December 26, 2022 updated by: Peking Union Medical College Hospital
The elderly patients over 65 years old with breast cancer have concomitant diseases, poor tolerance to conventional treatment, and the specific prognosis of breast cancer is relatively good. Previous studies on breast cancer have almost excluded elderly breast cancer patients, and conventional treatment schemes cannot meet the clinical diagnosis and treatment needs of elderly breast cancer patients. The establishment of a prognosis model for elderly breast cancer patients can provide personalized treatment programs. This is important for prolonging the survival time of patients and improving the quality of life. This project plans to observe the relationship between prognosis and pathological staging, molecular typing, and concomitant diseases of elderly breast cancer patients in combination with immune genes, and establish a prognosis model of elderly breast cancer and verify it. This project is expected to establish a new prognostic model for elderly breast cancer patients, accurately judge the prognosis of patients, and provide a new basis for hierarchical and personalized treatment of elderly breast cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Xuefei Wang
  • Phone Number: 0086-01069158720
  • Email: 5574571@qq.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

the patients ≥65 Years Old with breast cancer who received operaion in Peking Union Medical College Hospital

Description

Inclusion Criteria:

  • female patients with breast cancer
  • ≥65 Years Old
  • patients with breast cancer received operation in Peking Union Medical College Hospital
  • treatment regimen was made in Peking Union Medical College Hospital

Exclusion Criteria:

  • patients with metastasis
  • patietns with recurrence
  • patients without pathological information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-y DFS
Time Frame: 5 year
5-years of disease free survival
5 year
5-y BCSS
Time Frame: 5 year
5-year of breast cancer-specific survival
5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-y OS
Time Frame: 5 year
5-year overall survival
5 year
10-y DFS
Time Frame: 10 year
10-years of disease free survival
10 year
10-y BCSS
Time Frame: 10 year
10-year of breast cancer-specific survival
10 year
10-y OS
Time Frame: 10 year
10-year overall survival
10 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Ying Zhong, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

March 31, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

December 26, 2022

First Posted (Estimate)

January 11, 2023

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

December 26, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EEBC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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