East Asian Breast Cancer Genome Atlas and Recurrence Risk Prediction (TCGA-Asian)

The Cancer Genome Atlas and Recurrence Risk Prediction of East Asian Breast Cancer: a Multicenter Collaborative Study

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: PAM50

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Yen-Shen Lu, MD, PhD; Phone Number: +886-223123456; Email: yslu@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yen-Shen Lu, MD, PhD; Phone Number: +886-223123456; Email: yslu@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Stage I, II, III or IV Breast Cancer

Description

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.

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate	To establish the new platform for accurate prediction of recurrence	10 years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yen-Shen Lu, MD, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2018
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence
• Other Study ID Numbers: 201805027RSA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No