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

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ClinicalTrials.gov Identifier: NCT03053193
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : December 22, 2023
Sponsor:
Information provided by (Responsible Party):
Agendia

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Breast Cancer Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing

Detailed Description:

The FLEX Registry will include all patients with stage I-III breast cancer who have received MammaPrint and BluePrint testing in any clinical setting. Study arm appendices will specify treatment arm, inclusion criteria, and number of patients needed. Approximately 25,000 patients from 125+ US based institutions will be enrolled.

Treatment is at the discretion of the physician adhering to NCCN approved regimens of a recognized alternative.

Clinical data will be collected and entered online at the time points listed: patient enrollment, time of treatment, 1 year post-treatment, and 3, 5, and 10 years post diagnosis.

Objectives:

  • Create a large scale, population-based registry of full genome expression data and clinical data to investigate new gene associations with prognostic and/or predictive value
  • Utilize shared registry infrastructure to examine smaller groups of interest
  • Generate hypotheses for targeted subset analyses and trials based on full genome data

FLEX is an observational (phase IV) study.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 25000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)
Actual Study Start Date : April 28, 2017
Estimated Primary Completion Date : April 2037
Estimated Study Completion Date : December 2037

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
MammaPrint and BluePrint testing
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.
 Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing
Agendia will run MammaPrint and BluePrint tests using the full genome testing array.
Other Name: MammaPrint, BluePrint


Outcome Measures
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Primary Outcome Measures :
  1. A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created. [ Time Frame: 10 years ]
    Create a large scale registry of full genome expression data with clinical data to investigate possible new gene associations with prognostic or predictive value.

  2. A shared registry infrastructure to examine smaller groups of interest. [ Time Frame: 10 years ]
    Create a shared registry infrastructure to examine smaller groups of interest.


Secondary Outcome Measures :
  1. Subset analyses based on full genome data will be created. [ Time Frame: 10 years ]
    Use full genome data to analyze subsets.


Biospecimen Retention:   Samples With DNA
Tumor tissue acquired as part of a standard of care biopsy or surgical procedure will be sent to Agendia for testing.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will include patients with stage I, II, or III breast cancer that have signed an informed consent, and are eligible to receive chemotherapy and endocrine therapy. Patients will be excluded if they have metastatic disease or do not have ample tissue to send to Agendia for testing.
Criteria

Inclusion Criteria:

  • Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female)
  • Informed consent form signed on the same day or before enrollment
  • New primary lesion

Exclusion Criteria:

  • Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
  • Metastatic disease
  • Recurrent disease
  • Stage 0 disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053193


Contacts
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Contact: Christine Carruth 517-242-4181 christine.carruth@agendia.com

Locations
Show Show 118 study locations
Sponsors and Collaborators
Agendia
Investigators
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Study Director: William Audeh, MD Agendia, Inc.
Principal Investigator: Cynthia X Ma, MD Washington University School of Medicine
More Information
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Additional Information:

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Responsible Party: Agendia
ClinicalTrials.gov Identifier: NCT03053193    
Other Study ID Numbers: FLEX Registry
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: December 22, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Agendia:
breast cancer
stage I
stage II
stage III
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases