Recurrence Risk Evaluation by 21-gene Detection

Relationship and Consistency Analysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841266
• Other study ID #: KY2019
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2019
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 1, 2019
• Est. primary completion date: January 20, 2019
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Recurrence
• Relationship and Consistency Analysis

Intervention

Diagnostic Test:
• recurrence risk evaluation
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.

Locations

Country	Name	City	State
China	Xijing hoapital	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation analysis	x2 value and P value of chi-square test	Janyary 1, 2019-December 31, 2019
Secondary	consistency analysis	kappa value, P value of consistency analysis	Janyary 1, 2019-December 31, 2019