East Asian Breast Cancer Genome Atlas and Recurrence Risk Prediction

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT04344496
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

This project aims to establish the cancer genome atlas and the platform of recurrence risk prediction specific for East Asian breast cancer patients. The study was planned to collect blood sample, fresh tumor tissue, and paraffin embedded tumor tissue from 2000 patients. Aims to identify unique genetic alterations in Asian tumors, to identify the susceptible genes for breast carcinogenesis in East Asia, and to establish the new platform for accurate prediction of recurrence. The investigator will explore the association of patient outcomes with the genetic alterations from the cancer atlas of East Asian breast tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-18
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-14
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-07
• Primary Completion: 2021-10
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• 1. Aged more than 20-year-old at the time of informed consent.
• 2. An unconfirmed breast tumor, or have histologically confirmed invasive breast cancer.
• 3. Have radiological or objective evidence of breast tumor size ≥1 cm.
• 4. Be able to comply with study procedures to collect the clinical medical information, blood sample, fresh tumor tissue, and 12 sections of paraffin embedded tumor tissue.
• 5. Be able to sign an informed consent.

Read More

Exclusion Criteria

• 1. Have histologically confirmed ductal carcinoma in situ (DCIS).
• 2. Stage I, II or III breast cancer patients who have received neoadjuvant treatments, including chemotherapy, hormonal therapy, or targeted therapy.
• 3. Stage IV or metastatic breast cancer patients who have received chemotherapy.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of unique genetic alterations	3 years	To establish the cancer genome atlas and identify the susceptible genes for breast carcinogenesis in East Asia

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	10 years	To establish the new platform for accurate prediction of recurrence

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan