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MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles

NCT03053193 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30000

Last updated 2025-08-20

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

MammaPrint, BluePrint, and Full-Genome Testing

Agendia will run MammaPrint and BluePrint tests using the full genome testing array.

Sponsors & Collaborators

  • Agendia

    lead INDUSTRY

Principal Investigators

  • William Audeh, MD · Agendia, Inc.

  • Joyce O'Shaughnessy, MD · Texas Oncology - Baylor Charles A. Sammons Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-28
Primary Completion
2037-04-30
Completion
2037-12-31

Countries

  • United States
  • Canada
  • Greece
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03053193 on ClinicalTrials.gov