Breast CancerNCT03772197
Parallel Comparison of 18 Gene Classifiers and Oncotype DX (Nanostring)
An observational study of Breast Cancer and Recurrence, run by Amwise Diagnostics Pte. Ltd. at 1 site in Taiwan.
Trial summary
A recurrence index for distant recurrence (RI-DR), an 18-gene-based clinical-genomic model, has been developed for early-stage breast cancer (EBC). In this study, Investigators compared the prognostic performance of the RI-DR with the Oncotype DX (ODx) recurrence score (RS) for any recurrence risk type. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Recurrence
- How many people
- 138 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2018to 1 Nov 2018
- 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 75 years
- Women only
- Adult, Older adult
Study population: This study is a local validation and multi-center study. A total of 118 early-srage breast cancer (EBC) patients were included in this head-to-head comparison study, including 42, 15, and 81 patients treated between 2010 and 2016 at McKay Memorial Hospital, Koo Foundation Sun Yat-Sen Cancer Center, and National Taiwan University Hospital, respectively, in Taiwan
Who may be able to join
- Patients who have performed (Oncotype Dx) genetic testing methods before June 30, 2017.
- Surgery (mastectomy or breast preservation) as the first treatment.
- ER or PR IHC positive
- HER2 negative
- N0-N1 patient
- Available with FFPE tumor tissue
Who cannot join
- T3-T4 or N2-N3
- With distant metastasis before surgery
- Preoperative chemotherapy / radiotherapy
- Insufficient FFPE tumor samples
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Head-to-Head Comparison of 18-Gene-Based Clinical-Genomic Model and Oncotype DX 21-Gene Assay for Predicting Recurrence of Early-stage Breast Cancer
A recurrence index for distant recurrence (RI-DR), an 18-gene-based clinical-genomic model, has been developed for early-stage breast cancer (EBC). In this study, Investigators compared the prognostic performance of the RI-DR with the Oncotype DX (ODx) recurrence score (RS) for any recurrence risk type.
Read the detailed description
With improved diagnosis, breast cancer can now be detected at early stages, thus improving survival rates. However, overtreatment is common; considering that the risk of recurrence is low, patients may suffer from side effects without receiving the full benefits of adjuvant therapies.
To overcome the imprecision of prognosis based on clinicopathologic factors, genomic tests for breast cancer prognosis, such as the Oncotype DX® (ODx), MammaPrint®, and EndoPredict® assay kits, are frequently utilized. These multigene panels were development based on Caucasian populations, and may not suitable to Asian population due to the differences in the incidence and lifestyle of breast cancer patients from different ethic backgrounds. To fiil this gap, an 18-gene classifier (18-GC) based on the gene-expression profiling of Chinese breast cancer patients was developed
In the current study, investigators combined clinical variables and genetic information to generate a clinical-genomic model: RI-DR, a recurrence index for distant recurrence (based on a genomic model and 6 clinical variables: age, tumor size, lymph node status, estrogen receptor status, lymphovascular invasion, tumor grading).
By using tissues that have been tested with ODx, in this study, investigators evaluated the performance of the RI-DR model with that of the ODx assay in the prognosis assessment of a cohort of patients from Taiwan.
- Conditions
- Breast Cancer, Recurrence
- Keywords
- Breast cancer, Distant recurrence, NanoString, Gene-expression profiling, Prognosis, Locoreginal recurrence
- Medical subject headings
- Breast Neoplasms, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
The locoregional recurrence (LRR) rate, within 5 years after surgery.
LRR risk calculated by 18-GC of breast cancer patients would be classified into high risk
Measured: 5 years
The distant recurrence(DR) rate, within 5 years after surgery.
DR risk calculated by 18-GC of breast cancer patients would be classified into high risk
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start1 Jun 2018
- Primary completion18 Oct 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amwise Diagnostics Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Skye Cheng, Principal investigator, AMWISE DIAGNOSTICS PTE. LDT.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772197
- Sponsor's protocol ID
- RI-002
- Status last verified
- Dec 2018
- First submitted
- 10 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-to-Head Comparison of 18-Gene-Based Clinical-Genomic Model and Oncotype DX 21-Gene Assay for Predicting Recurrence of Early-stage Breast Cancer
- ClinicalTrials.gov ID
- NCT03772197
- Acronym / sponsor ID
- RI-002
- Conditions
- Breast Cancer, Recurrence
- Keywords
- Breast cancer, Distant recurrence, NanoString, Gene-expression profiling, Prognosis, Locoreginal recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Amwise Diagnostics Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 11 Dec 2018 (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.
A recurrence index for distant recurrence (RI-DR), an 18-gene-based clinical-genomic model, has been developed for early-stage breast cancer (EBC). In this study, Investigators compared the prognostic performance of the RI-DR with the Oncotype DX (ODx) recurrence score (RS) for any recurrence risk type.
Detailed description
With improved diagnosis, breast cancer can now be detected at early stages, thus improving survival rates. However, overtreatment is common; considering that the risk of recurrence is low, patients may suffer from side effects without receiving the full benefits of adjuvant therapies.
To overcome the imprecision of prognosis based on clinicopathologic factors, genomic tests for breast cancer prognosis, such as the Oncotype DX® (ODx), MammaPrint®, and EndoPredict® assay kits, are frequently utilized. These multigene panels were development based on Caucasian populations, and may not suitable to Asian population due to the differences in the incidence and lifestyle of breast cancer patients from different ethic backgrounds. To fiil this gap, an 18-gene classifier (18-GC) based on the gene-expression profiling of Chinese breast cancer patients was developed
In the current study, investigators combined clinical variables and genetic information to generate a clinical-genomic model: RI-DR, a recurrence index for distant recurrence (based on a genomic model and 6 clinical variables: age, tumor size, lymph node status, estrogen receptor status, lymphovascular invasion, tumor grading).
By using tissues that have been tested with ODx, in this study, investigators evaluated the performance of the RI-DR model with that of the ODx assay in the prognosis assessment of a cohort of patients from Taiwan.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- This study is a local validation and multi-center study. A total of 118 early-srage breast cancer (EBC) patients were included in this head-to-head comparison study, including 42, 15, and 81 patients treated between 2010 and 2016 at McKay Memorial Hospital, Koo Foundation Sun Yat-Sen Cancer Center, and National Taiwan University Hospital, respectively, in Taiwan
Key inclusion criteria (6 listed)
- Patients who have performed (Oncotype Dx) genetic testing methods before June 30, 2017.
- Surgery (mastectomy or breast preservation) as the first treatment.
- ER or PR IHC positive
- HER2 negative
- N0-N1 patient
Key exclusion criteria (4 listed)
- T3-T4 or N2-N3
- With distant metastasis before surgery
- Preoperative chemotherapy / radiotherapy
- Insufficient FFPE tumor samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The locoregional recurrence (LRR) rate, within 5 years after surgery.
Time frame: 5 years
LRR risk calculated by 18-GC of breast cancer patients would be classified into high risk
The distant recurrence(DR) rate, within 5 years after surgery.
Time frame: 5 years
DR risk calculated by 18-GC of breast cancer patients would be classified into high risk
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 19 Dec 2018.
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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.
Skye Cheng principal investigator
AMWISE DIAGNOSTICS PTE. LDT.
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 Breast Cancer and Recurrence, run by Amwise Diagnostics Pte. Ltd. at 1 site in Taiwan.
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 6 inclusion and 4 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 19 Dec 2018. 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 Taiwan. 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?
The locoregional recurrence (LRR) rate, within 5 years after surgery. (time frame: 5 years). The study lists 2 primary outcomes in all. 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 19 Dec 2018.