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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04344496
Collaborator
(none)
2,000
Enrollment
1
Location
116.4
Anticipated Duration (Months)
17.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: PAM50

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Cancer Genome Atlas and Recurrence Risk Prediction of East Asian Breast Cancer: a Multicenter Collaborative Study
Actual Study Start Date :
Oct 18, 2018
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Jul 1, 2028

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Recurrence rate [10 years]

    To establish the new platform for accurate prediction of recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Aged more than 20-year-old at the time of informed consent.
    1. An unconfirmed breast tumor, or have histologically confirmed invasive breast cancer.
    1. Have radiological or objective evidence of breast tumor size ≥1 cm.
    1. 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.
    1. Be able to sign an informed consent.
Exclusion Criteria:
    1. Have histologically confirmed ductal carcinoma in situ (DCIS).
    1. Stage I, II or III breast cancer patients who have received neoadjuvant treatments, including chemotherapy, hormonal therapy, or targeted therapy.
    1. Stage IV or metastatic breast cancer patients who have received chemotherapy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT04344496
Other Study ID Numbers:
  • 201805027RSA
First Posted:
Apr 14, 2020
Last Update Posted:
May 7, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms
Recurrence

Study Results

No Results Posted as of May 7, 2021