Familial Breast Cancer in China

February 13, 2025 updated by: PENG YUAN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Real-world Study of Familial Hereditary Breast Cancer in China

This study is a retrospective descriptive study to collect clinical data (mainly including medical records and follow-up information, etc.) of breast cancer patients with genetic variation who were first diagnosed and treated in a number of hospitals in China during the period from January 1, 2015 to December 31, 2024, and to establish a retrospective cohort of familial hereditary breast cancer. To analyze the clinical features, diagnosis and treatment and survival prognosis of patients with familial hereditary breast cancer. To explore the main factors affecting clinical diagnosis and treatment and survival prognosis of patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

From January 1, 2015 to December 31, 2024, a number of hospitals in China first diagnosed and treated breast cancer patients with genetic variants

Description

Inclusion Criteria:

  • Familial inherited breast cancer with genetic variants, including but not limited to mutations in the BRCA1, BRCA2, TP53, and PALB2 genes
  • The patient had no major organ dysfunction
  • ECOG score 0-1

Exclusion Criteria:

  • There are serious dysfunction of vital organs (heart, liver, kidney)
  • Patients with other malignancies, except cured non-melanoma skin cancer, cervical carcinoma in situ and other tumors that have been cured for at least 5 years
  • In other acute infectious disease or chronic infectious disease activity period
  • A history of uncontrolled seizures, central nervous system disorders, or mental disorders

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
Familial breast cancer
Familial inherited breast cancer with genetic variants, including but not limited to mutations in the BRCA1, BRCA2, TP53, and PALB2 genes
Other: Genetic variation
To observe and describe the clinical features, diagnosis and treatment plan and survival prognosis of familial hereditary breast cancer in China, and explore the main factors affecting prognosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival rate
Time Frame: 5-year
5-year

Collaborators and Investigators

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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 (Estimated)

February 28, 2025

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2035

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC5164

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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