Menu
Recruiting NCT04344496

East Asian Breast Cancer Genome Atlas and Recurrence Risk Prediction

Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PAM50.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Prevalence of unique genetic alterations [Time frame: 3 years]
Secondary outcome measures (1)
  • Recurrence rate [Time frame: 10 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT04344496 · 201805027RSA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗