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Completed

NCT Number: NCT02669745

The Study of Molecular Risk Panels (70-gene Assay) in Chinese Breast Cancer Patients

This study is experimental and will prospectively assess the proportion of patients in the two (2) MammaPrint Risk categories in patients of Chinese descent.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Agendia

Industry

Registry information

Official study title

The Study of Molecular Risk Panels in Chinese Breast Cancer Patient Using Mammaprint, TargetPrint, BluePrint and Research Gene Panel Assays.

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Feb 1, 2016
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.