Familial Breast Cancer in China

NCT06833216 | Not Yet Recruiting

• 1 other identifier: NCC5164
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Carcinoma; Genetic Variation

Outcome Measures

Primary Outcomes (1)

• Overall survival rate

  5-year

Study Arms (1)

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

Interventions

Genetic variation OTHER

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.

Familial breast cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Genetic Variation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Central Study Contacts

Xue Wang

CONTACT

86-010-87787242; wxyxyuki@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: February 28, 2025
• Primary Completion: February 28, 2025
• Study Completion (Estimated): February 28, 2035
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

CN (1)