Chinese Clinical Trial
Official title:
The Study of Molecular Risk Panels in Chinese Breast Cancer Patient Using Mammaprint, TargetPrint, BluePrint and Research Gene Panel Assays.
NCT number | NCT02669745 |
Other study ID # | P-0125 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2012 |
Est. completion date | May 2019 |
Verified date | July 2019 |
Source | Agendia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is experimental and will prospectively assess the proportion of patients in the two (2) MammaPrint Risk categories in patients of Chinese descent.
Status | Completed |
Enrollment | 64 |
Est. completion date | May 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Stage II Breast Cancer with more than 3 positive lymph nodes |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Agendia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 weeks |
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