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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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03841266
Enrollment
220
Registered
2019-02-15
Start date
2019-01-01
Completion date
2019-02-01
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relationship and Consistency Analysis

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.

Interventions

DIAGNOSTIC_TESTrecurrence 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.

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years

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

Design outcomes

Primary

MeasureTime frameDescription
correlation analysisJanyary 1, 2019-December 31, 2019x2 value and P value of chi-square test

Secondary

MeasureTime frameDescription
consistency analysisJanyary 1, 2019-December 31, 2019kappa value, P value of consistency analysis

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026