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OpenTrials
Completed

NCT Number: NCT03841266

Recurrence Risk Evaluation by 21-gene Detection

Breast cancer patients with early breast cancer were enrolled according to the inclusion criteria. Baseline characteristics were recorded from medical record system. Recurrence score were obtained by 21-gene detection kits from different biological companies. Relationship between recurrence score and the prognosis was explored. Meanwhile, the investigators analyzed the consistency of the results obtained from various 21-gene test kits and immunohistochemistry detection.

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Key information

Conditions

Relationship and Consistency Analysis

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Xijing hoapital

Xi'an, 710032, China

Who can participate

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

Inclusion criteria

  • breast cancer in stage I-III, tumor size>0.5cm
  • lymph nodes negative
  • hormone receptor positive （ER+/PR+,ER+/PR-,ER-/PR+）
  • HER2 negative（IHC 0 or +， FISH negative）
  • receive endocrine therapy only
  • enough FFPE samples within 10 years（3~6 10μm ）
  • patients with integrated medical records

Exclusion criteria

  • Tumor cells <5%
  • Isolated RNA<500ng

Treatment and study plan

recurrence risk evaluation

Diagnostic Test

Recurrence score were obtained by 21-gene detection kits from different biological companies. The expression of ER, PR, and Her-2 were also detected by IHC.

Primary outcomes

  1. correlation analysis

    Time frame: Janyary 1, 2019-December 31, 2019

    x2 value and P value of chi-square test

Secondary outcomes

  1. consistency analysis

    Time frame: Janyary 1, 2019-December 31, 2019

    kappa value, P value of consistency analysis

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Postoperative Recurrence Risk Evaluation of Hormone Receptor Positive, Her-2 Negative Breast Cancer by Using Different 21-gene Detection Kits (REBCK)

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2019
Registry last updated
Feb 15, 2019

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.