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

NCT ID: NCT02669745

Last Updated: 2019-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2019-05-31

Brief Summary

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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

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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

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Chinese

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Agendia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Columbia University Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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P-0125

Identifier Type: -

Identifier Source: org_study_id

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