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CompletedNCT03841266Updated Feb 15, 2019

Recurrence Risk Evaluation by 21-gene Detection

An observational study in Relationship and Consistency Analysis, sponsored by Xijing Hospital. Completed at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Xijing Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
220
Ages
18 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Relationship and Consistency Analysis

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03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's enrollment of 220 is close to the median of 200 across 702 observational studies indexed under Recurrence.

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Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Sampling method
Probability sample

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.

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

Exclusion Criteria:

  1. Tumor cells \<5%
  2. Isolated RNA\<500ng
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
220 participants (actual)
Patient registry
No

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.

06

What researchers measure

Primary outcomes

  1. correlation analysis

    x2 value and P value of chi-square test

    Time frame: Janyary 1, 2019-December 31, 2019

Secondary outcomes

  1. consistency analysis

    kappa value, P value of consistency analysis

    Time frame: Janyary 1, 2019-December 31, 2019

07

Study locations

1 site
  • Xijing hoapital
    Xi'an, 710032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03841266
Lead sponsor
Xijing Hospital
Responsible party
LiNanlin,Ph.D, Chief Physician,Clinical Professor (Professor, Thyroid breast and vascular surgery, Principal Investigator, Xijing Hospital) — Principal investigator
First posted
Feb 15, 2019
Start date
Jan 1, 2019
Primary completion
Jan 20, 2019
Completion
Feb 1, 2019
Last update
Feb 15, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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