ChineseNCT02669745
The Study of Molecular Risk Panels (70-gene Assay) in Chinese Breast Cancer Patients
An observational study of Chinese, run by Agendia at 1 site in United States.
Trial summary
This study is experimental and will prospectively assess the proportion of patients in the two (2) MammaPrint Risk categories in patients of Chinese descent. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Chinese
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to May 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
- No healthy volunteers
- Adult, Older adult
Study population: Women of Chinese Descent with Stage I or Stage II Breast Cancer
Who may be able to join
- Females aged 18 year to 70 year,
- diagnosis of Stage I or Stage II (excluding those involving more than 3 lymph nodes) Breast Cancer
- Chinese descent
Who cannot join
- Stage II Breast Cancer with more than 3 positive lymph nodes
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: The Study of Molecular Risk Panels in Chinese Breast Cancer Patient Using Mammaprint, TargetPrint, BluePrint and Research Gene Panel Assays.
This study is experimental and will prospectively assess the proportion of patients in the two (2) MammaPrint Risk categories in patients of Chinese descent.
Read the detailed description
The incidence of breast cancer in Chinese women is lower than that of a Western population. Breast cancer is the most common cancer in Chinese women and the incidence is rising. Moreover there are more premenopausal women with breast cancer where the breast cancer incidence peaks in the forties and the postmenopausal rise in incidence is less commonly seen. As the genetic predisposition to breast cancer is increasingly understood, it has been suggested that the differences in breast cancer incidence in different ethnic populations is potentially due to interactions between lifestyle and genetic characteristics. To date, the use of Agendia's gene expression assays in Chinese women has not been studied. In this study, the feasibility of the gene-expression prognostic assays for risk assessment in this specific group will be assessed. Moreover, the specific molecular characteristics and potential biomarkers will be studied, focusing especially on the large group of premenopausal breast cancer patients.
- Conditions
- Chinese
- Keywords
- Chinese women, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women of Chinese Descent | Females of Chinese descent, aged 18 year to 70 year, diagnosed with Stage 1 or Stage 2 (excluding those involving more than 3 lymph nodes) breast cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing MammaPrint with Clinical Risk Assessment
The MammaPrint risk assessment outcomes will be compared with conventionally used risk assessments determined by clinical parameters, standard staging and IHC analysis (Adjuvant! Online) in a population of Chinese patients with breast cancer.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJan 2012
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChineseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agendia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669745
- Sponsor's protocol ID
- P-0125
- Status last verified
- Jul 2019
- First submitted
- 28 Jan 2016
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Molecular Risk Panels in Chinese Breast Cancer Patient Using Mammaprint, TargetPrint, BluePrint and Research Gene Panel Assays.
- ClinicalTrials.gov ID
- NCT02669745
- Acronym / sponsor ID
- P-0125
- Conditions
- Chinese
- Keywords
- Chinese women, Breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AgendiaIndustry (pharma, biotech, devices)
- Study start
- Jan 2012 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 1 Feb 2016 (estimated)
- 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.
This study is experimental and will prospectively assess the proportion of patients in the two (2) MammaPrint Risk categories in patients of Chinese descent.
Detailed description
The incidence of breast cancer in Chinese women is lower than that of a Western population. Breast cancer is the most common cancer in Chinese women and the incidence is rising. Moreover there are more premenopausal women with breast cancer where the breast cancer incidence peaks in the forties and the postmenopausal rise in incidence is less commonly seen. As the genetic predisposition to breast cancer is increasingly understood, it has been suggested that the differences in breast cancer incidence in different ethnic populations is potentially due to interactions between lifestyle and genetic characteristics. To date, the use of Agendia's gene expression assays in Chinese women has not been studied. In this study, the feasibility of the gene-expression prognostic assays for risk assessment in this specific group will be assessed. Moreover, the specific molecular characteristics and potential biomarkers will be studied, focusing especially on the large group of premenopausal breast cancer patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women of Chinese Descent | – | –Females of Chinese descent, aged 18 year to 70 year, diagnosed with Stage 1 or Stage 2 (excluding those involving more than 3 lymph nodes) breast cancer. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women of Chinese Descent with Stage I or Stage II Breast Cancer
Key inclusion criteria (3 listed)
- Females aged 18 year to 70 year,
- diagnosis of Stage I or Stage II (excluding those involving more than 3 lymph nodes) Breast Cancer
- Chinese descent
Key exclusion criteria (1 listed)
- Stage II Breast Cancer with more than 3 positive lymph nodes
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
Comparing MammaPrint with Clinical Risk Assessment
Time frame: 6 weeks
The MammaPrint risk assessment outcomes will be compared with conventionally used risk assessments determined by clinical parameters, standard staging and IHC analysis (Adjuvant! Online) in a population of Chinese patients with breast cancer.
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 2 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Chinese, run by Agendia at 1 site in United States.
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 3 inclusion and 1 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 2 Jul 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 United States. 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?
Comparing MammaPrint with Clinical Risk Assessment (time frame: 6 weeks). 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 2 Jul 2019.