Relationship and Consistency AnalysisNCT03841266
Recurrence Risk Evaluation by 21-gene Detection
An observational study of Relationship and Consistency Analysis, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Relationship and Consistency Analysis
- What is being tested?
- recurrence risk evaluation
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- Tumor cells <5%
- Isolated RNA<500ng
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Recurrence Risk Evaluation of Hormone Receptor Positive, Her-2 Negative Breast Cancer by Using Different 21-gene Detection Kits (REBCK)
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.
- Conditions
- Relationship and Consistency Analysis
- Being tested
- recurrence risk evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recurrence risk evaluationDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation analysis
x2 value and P value of chi-square test
Measured: Janyary 1, 2019-December 31, 2019
Secondary outcomes (1)
consistency analysis
kappa value, P value of consistency analysis
Measured: Janyary 1, 2019-December 31, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jan 2019
- Primary completion20 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relationship and Consistency AnalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841266
- Sponsor's protocol ID
- KY2019
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Recurrence Risk Evaluation of Hormone Receptor Positive, Her-2 Negative Breast Cancer by Using Different 21-gene Detection Kits (REBCK)
- ClinicalTrials.gov ID
- NCT03841266
- Acronym / sponsor ID
- KY2019
- Conditions
- Relationship and Consistency Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Tumor cells <5%
- Isolated RNA<500ng
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recurrence risk evaluationRecurrence 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. | Diagnostic test | – |
Primary outcome
correlation analysis
Time frame: Janyary 1, 2019-December 31, 2019
x2 value and P value of chi-square test
1 secondary outcome
consistency analysis
Time frame: Janyary 1, 2019-December 31, 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relationship and Consistency Analysis, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation analysis (time frame: Janyary 1, 2019-December 31, 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.