the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis
November 25, 2019 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
A Retrospective, International Multicenter, Single Arm Clinical Trial of the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis
Geneswell BCT is a precise and qualitative in vitro diagnostic test. The expression of 9 genes was obtained from the formalin fixed paraffin embedded block (FFPE) of breast cancer tissue samples by RT-qPCR, and the patients were divided into high-risk group and low-risk group.
This test provides prognostic information to assess the risk of recurrence. The BCT score calculated by geneswell BCT was associated with the risk of recurrence. The higher the BCT score, the more likely it is to relapse, and vice versa.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
100
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Women with hormone receptor positive (estrogen, ER + or progesterone PR +, HER2 negative, and pN0 or PN1) early breast cancer
Description
Inclusion Criteria:
- The patients were diagnosed with invasive breast cancer with positive hormone receptor (including positive estrogen receptor or progesterone receptor) and negative human epidermal growth factor receptor 2 (HER2)
- Axillary lymph node assessment : pN0 or PN1
- Women aged 18 and over
- Patients without chemotherapy after operation
Exclusion Criteria:
- Patients with negative hormone receptor （both estrogen and progesterone receptor are negative）
- Human epidermal growth factor receptor 2 （HER2） positive
- Pathological nodule evaluation: pN2 or pN3
- Male patients
- Patients receiving chemotherapy after surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
low risk
BCT Score <4
|
Geneswell BCT is a precise and qualitative in vitro diagnostic test.
The expression of 9 genes was obtained from the formalin fixed paraffin embedded block (FFPE) of breast cancer tissue samples by RT-qPCR, and the patients were divided into high-risk group and low-risk group.
|
|
high risk
BCT Score ≥4
|
Geneswell BCT is a precise and qualitative in vitro diagnostic test.
The expression of 9 genes was obtained from the formalin fixed paraffin embedded block (FFPE) of breast cancer tissue samples by RT-qPCR, and the patients were divided into high-risk group and low-risk group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparative assessment between risk groups
Time Frame: Month 9
|
By evaluating the 5-year disease-free survival rate (DFS) of patients in high and low risk groups, the statistical differences between the two groups were compared.
|
Month 9
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2020
Primary Completion (Anticipated)
October 31, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
October 15, 2019
First Submitted That Met QC Criteria
November 25, 2019
First Posted (Actual)
November 27, 2019
Study Record Updates
Last Update Posted (Actual)
November 27, 2019
Last Update Submitted That Met QC Criteria
November 25, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YANWQ002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.