Recurrence Risk Evaluation by 21-gene Detection

NCT ID: NCT03841266

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-02-01

Brief Summary

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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

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Conditions

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Relationship and Consistency Analysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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LiNanlin,Ph.D, Chief Physician,Clinical Professor

Professor, Thyroid breast and vascular surgery, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xijing hoapital

Xi'an, , China

Site Status

Countries

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China

Other Identifiers

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KY2019

Identifier Type: -

Identifier Source: org_study_id

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