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NCT Number: NCT04344496

East Asian Breast Cancer Genome Atlas and Recurrence Risk Prediction

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location status: Recruiting

Location contact

Yen-Shen Lu, MD, PhD

CONTACT

[email protected]

+886-223123456

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PAM50

Other

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

Primary outcomes

  1. Prevalence of unique genetic alterations

    Time frame: 3 years

    To establish the cancer genome atlas and identify the susceptible genes for breast carcinogenesis in East Asia

Secondary outcomes

  1. Recurrence rate

    Time frame: 10 years

    To establish the new platform for accurate prediction of recurrence

Study contacts

Contact information is provided by the study sponsor or research team.

Yen-Shen Lu, MD, PhD

CONTACT

[email protected]

+886-223123456

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2028
First posted
Apr 14, 2020
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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