East Asian Breast Cancer Genome Atlas and Recurrence Risk Prediction

Breast Cancer Clinical Trial

— TCGA-Asian  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04344496
• Other study ID #: 201805027RSA
• Status: Recruiting
• Start date: October 18, 2018
• Est. completion date: July 2028

Study information

• Verified date: May 2021
• Source: National Taiwan University Hospital
• Contact: Yen-Shen Lu, MD, PhD
• Phone: +886-223123456
• Email: yslu[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 2028
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Recurrence

Intervention

Other:
• PAM50
PAM50 results is as one of the references for the physicians and the participants to choose adjuvant treatments.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recurrence rate	To establish the new platform for accurate prediction of recurrence	10 years