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Clinical performance study of breast cancer prognostic diagnosticsGenesWell™ BCT in Korean patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer

Clinical performance study of breast cancer prognostic diagnosticsGenesWell™ BCT in Korean patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0004263
Enrollment
500
Registered
2019-08-30
Start date
2017-05-01
Completion date
Unknown
Last updated
2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.1. Selection criteria 1.1.1. Criteria for Selection of Sample Providers 1) hormone receptor positive (ER+ and/or PR+) 2) Human epidermal growth factor receptor type2 negative (HER2-) 3) pN0 or pN1 is applicable 4) Female patients 1.1.2. Criteria for selecting remaining samples 1) Residual samples containing the collected tissue with paraffin (FFPE residual samples) 2) In case pathological samples that are not obstructed in future care are stored

Exclusion criteria

Exclusion criteria: 1.1.1. Exclusion Criteria for Sample Providers 1) For hormone receptor negative (ER- and PR-) 2) Human epidermal growth factor receptor type2 (HER2+) 3) pN2, or pN3 is applicable 1.1.2. Exclusion Criteria for Residual Specimens 1) Remaining samples not covered with paraffin (non-FFPE residual samples) 2) Pathologists have determined that the condition of the FFPE block is not available for clinical trials in tissue and pathology

Design outcomes

Secondary

MeasureTime frame
Disease free survival;overall survival;Breast cancer specific survival

Primary

MeasureTime frame
Distant metastasis free survival

Countries

Korea, Republic of

Contacts

Public ContactJai Min Ryu

Samsung Medical Center

snowman120@hanmail.net+82-2-3410-1319

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026