Recurrence Risk Evaluation by 21-gene Detection | NCT03841266

Studies
Recurrence Risk Evaluation by 21-gene Detection

NCT03841266

Sponsor

Xijing Hospital

Status

Completed

Last Update Posted

Feb 15, 2019Actual

Enrollment

220Actual

Phase

Not provided

Conditions

Relationship and Consistency Analysis

Interventions

recurrence risk evaluation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jan 20, 2019Actual

Completion Date

Feb 1, 2019Actual

First Submitted Date

Feb 11, 2019

First Submission Date that Met QC Criteria

Feb 12, 2019

First Posted Date

Feb 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2019

Last Update Posted Date

Feb 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

LiNanlin,Ph.D, Chief Physician,Clinical Professor, Professor, Thyroid breast and vascular surgery, Principal Investigator, Xijing HospitalPrincipal Investigator

Lead Sponsor

Xijing HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
recurrence risk evaluation	Diagnostic Test	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Tumor cells <5%
Isolated RNA<500ng

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample