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Gene Expression Profiling

MammaPrint and BluePrint testing for Breast Cancer (FLEX Trial)

N/A
Recruiting
Led By Cynthia X Ma, MD
Research Sponsored by Agendia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Summary

The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created.
A shared registry infrastructure to examine smaller groups of interest.
Secondary outcome measures
Subset analyses based on full genome data will be created.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MammaPrint and BluePrint testingExperimental Treatment1 Intervention
All patients will receive MammaPrint and BluePrint testing using the full-genome testing data chip. Treatment will be at the discretion of the physician while adhering to NCCN guidelines.

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Who is running the clinical trial?

AgendiaLead Sponsor
17 Previous Clinical Trials
14,120 Total Patients Enrolled
8 Trials studying Breast Cancer
9,729 Patients Enrolled for Breast Cancer
William Audeh, MDStudy DirectorAgendia, Inc.
Cynthia X Ma, MDPrincipal InvestigatorWashington University School of Medicine
~15690 spots leftby Apr 2037
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