NCT02669745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

July 2, 2019

Status Verified

July 1, 2019

Enrollment Period

7.3 years

First QC Date

January 28, 2016

Last Update Submit

July 1, 2019

Conditions

Chinese

Keywords

Chinese womenBreast cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women of Chinese Descent with Stage I or Stage II Breast Cancer

You may qualify if:

  • 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

You may not qualify if:

  • Stage II Breast Cancer with more than 3 positive lymph nodes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 1, 2016

Study Start

January 1, 2012

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

July 2, 2019

Record last verified: 2019-07

Locations

US(1)