The Characteristics, Treatment Patterns and Prognosis of Chinese Male Breast Cancer: A Real-world Study
January 13, 2024 updated by: Ying Lin, First Affiliated Hospital, Sun Yat-Sen University
The goal of this observational study is to investigate the features in Chinese male breast cancer (MBC) patients. The main question it aims to answer is:
- The characteristics, treatment patterns and prognosis of Chinese MBC patients. The clinicopathological characteristics, treatment information and follow-up data of participants will be extracted from a Chinese national database (Chinese Society of Clinical Oncology Breast Cancer database) and other involved Chinese centers.
Researchers will investigate the features, survival associated factors and other relevant factors of this population.
Study Overview
Detailed Description
The goal of this observational study is to investigate the features in Chinese male breast cancer (MBC) patients. The main question it aims to answer is:
- The characteristics, treatment patterns and prognosis of Chinese MBC patients. The clinicopathological characteristics, treatment information and follow-up data of participants will be extracted from a Chinese national database (Chinese Society of Clinical Oncology Breast Cancer database) and other involved Chinese centers.
Researchers will investigate the features, survival associated factors and other relevant factors of this population.
The collected variables included: survival time, survival status, year of diagnosis, age, stage, molecular subtype statuses, histology, grade, and surgery, radiotherapy and systemic therapies utilization.
Study Type
Observational
Enrollment (Estimated)
1200
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
- Name: Yuxuan Gao, MD
- Phone Number: +86 18142846375
- Email: gaoyx9@mail2.sysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510030
- Recruiting
- First Affiliated Hospital of Sun Yat-sen University
-
Contact:
- Yuxuan Gao, MD
- Phone Number: +8618142846375
- Email: gaoyx9@mail2.sysu.edu.cn
-
Principal Investigator:
- Ying Lin, MD, PhD
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All eligible cases were collected from a Chinese national database (Chinese Society of Clinical Oncology Breast Cancer database) and other involved centers.
Description
Inclusion Criteria:
- Biological sex is male;
- Microscopically diagnosed as primary breast cancer.
Exclusion Criteria:
- Presence of skin-origin malignancy on the breast.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Chinese
About 1,200 Chinese male breast cancer cases are anticipated to collected retrospectively.
The clinicopathological characteristics, treatment and survival information are retrospectively collected.
|
Male patients who were microscopically diagnosed as primary breast cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: From the time of diagnosis to August 1, 2024 (anticipated).
|
The duration between the date of the first pathologic diagnosis and death from any cause or last follow-up.
|
From the time of diagnosis to August 1, 2024 (anticipated).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ying Lin, MD, PhD, 1st affiliated hospital of Sun Yat-sen university
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)
August 1, 2021
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
January 13, 2024
First Submitted That Met QC Criteria
January 13, 2024
First Posted (Estimated)
January 24, 2024
Study Record Updates
Last Update Posted (Estimated)
January 24, 2024
Last Update Submitted That Met QC Criteria
January 13, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021[516]
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
A part of Chinese data that support the findings of this study are available from Chinese Society of Clinical Oncology Breast Cancer Database but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available.
Chinese data are however available from the corresponding author upon reasonable request and with permission of Chinese Society of Clinical Oncology Breast Cancer Database.
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.