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

Sponsor
Agendia (Industry)
Overall Status
Completed
CT.gov ID
NCT02669745
Collaborator
(none)
64
Enrollment
1
Location
88
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    64 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    The Study of Molecular Risk Panels in Chinese Breast Cancer Patient Using Mammaprint, TargetPrint, BluePrint and Research Gene Panel Assays.
    Actual Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    May 1, 2019
    Actual Study Completion Date :
    May 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Comparing MammaPrint with Clinical Risk Assessment [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University Medical Center New York New York United States 10032

    Sponsors and Collaborators

    • Agendia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Agendia
    ClinicalTrials.gov Identifier:
    NCT02669745
    Other Study ID Numbers:
    • P-0125
    First Posted:
    Feb 1, 2016
    Last Update Posted:
    Jul 2, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Agendia
    Chinese women
    Breast cancer
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jul 2, 2019