Recurrence Risk Evaluation by 21-gene Detection

Completed

• Conditions: Relationship and Consistency Analysis

• Registration Number: NCT03841266
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-01-20
• Status Verified: 2019-02
• Study Completion: 2019-02-01
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-12
• Last Update Submitted: 2019-02-12
• Study First Posted: 2019-02-15
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
correlation analysis	Janyary 1, 2019-December 31, 2019	x2 value and P value of chi-square test

Secondary Outcome Measures

Name	Time	Method
consistency analysis	Janyary 1, 2019-December 31, 2019	kappa value, P value of consistency analysis

Trial Locations

Locations (1)

Xijing hoapital; 🇨🇳 Xi'an, China