East Asian Breast Cancer Genome Atlas and Recurrence Risk Prediction

NCT04344496 | Recruiting

• 1 other identifier: 201805027RSA
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Recurrence rate

  10 years

Interventions

PAM50 OTHER

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Stage I, II, III or IV Breast Cancer

You may qualify if:

• \. Aged more than 20-year-old at the time of informed consent.
• \. An unconfirmed breast tumor, or have histologically confirmed invasive breast cancer.
• \. Have radiological or objective evidence of breast tumor size ≥1 cm.
• \. 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.
• \. Be able to sign an informed consent.

You may not qualify if:

• \. Have histologically confirmed ductal carcinoma in situ (DCIS).
• \. Stage I, II or III breast cancer patients who have received neoadjuvant treatments, including chemotherapy, hormonal therapy, or targeted therapy.
• \. Stage IV or metastatic breast cancer patients who have received chemotherapy.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Yen-Shen Lu, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yen-Shen Lu, MD, PhD

CONTACT

+886-223123456; yslu@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 14, 2020
• Study Start: October 18, 2018
• Primary Completion: October 1, 2025
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

TW (1)