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Clinical Trials/KCT0004263
KCT0004263
Recruiting
未知

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

Samsung Medical Center0 sites500 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Samsung Medical Center
Enrollment
500
Status
Recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
6 years ago
Study Type
Observational Study
Sex
Female

Investigators

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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