East Asian Breast Cancer Genome Atlas and Recurrence Risk Prediction

NCT ID: NCT04344496

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-18

Study Completion Date

2028-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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PAM50

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yen-Shen Lu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yen-Shen Lu, MD, PhD

Role: CONTACT

+886-223123456

Facility Contacts

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Yen-Shen Lu, MD, PhD

Role: primary

+886-223123456

Other Identifiers

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201805027RSA

Identifier Type: -

Identifier Source: org_study_id

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