Recurrence Risk Evaluation by 21-gene Detection

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

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.

Study Overview

• Status: Completed
• Conditions: Relationship and Consistency Analysis
• Intervention / Treatment: Diagnostic test: recurrence risk evaluation

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• China
  • Xi'an, China, 710032
    • Xijing hoapital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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, we analyzed the consistency of the results obtained from various 21-gene test kits and immunohistochemistry detection.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Tumor cells <5%
2. Isolated RNA<500ng

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation analysis	x2 value and P value of chi-square test	Janyary 1, 2019-December 31, 2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
consistency analysis	kappa value, P value of consistency analysis	Janyary 1, 2019-December 31, 2019

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 20, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: KY2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No