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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 : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Agendia

Tracking Information
First Submitted Date February 9, 2017
First Posted Date February 15, 2017
Last Update Posted Date July 3, 2019
Actual Study Start Date April 28, 2017
Estimated Primary Completion Date April 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: February 10, 2017)
  • 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 ]
  • A shared registry infrastructure to examine smaller groups of interest. [ Time Frame: 10 years ]
Change History Complete list of historical versions of study NCT03053193 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 1, 2019)
Subset analyses based on full genome data will be created. [ Time Frame: 10 years ]
Use full genome data to analyze subsets.
Original Secondary Outcome Measures
 (submitted: February 10, 2017)
Subset analyses based on full genome data will be created. [ Time Frame: 10 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles
Official Title MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)
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.
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 2000 patients from 70-75 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 2, 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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Retention:   Samples With DNA
Description:
Tumor tissue acquired as part of a standard of care biopsy or surgical procedure will be sent to Agendia for testing.
Sampling Method Non-Probability Sample
Study Population Study population will include patients with stage I to 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.
Condition Breast Cancer
Intervention Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing
Agendia will run MammaPrint and BluePrint tests using the DiscoverPrint testing array.
Other Name: MammaPrint, BluePrint, DiscoverPrint
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 2, 2018)
10000
Original Estimated Enrollment
 (submitted: February 10, 2017)
2000
Estimated Study Completion Date December 2027
Estimated Primary Completion Date April 2027   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sarah Untch, MS 412-770-6906 sarah.untch@agendia.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03053193
Other Study ID Numbers FLEX Registry
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Agendia
Study Sponsor Agendia
Collaborators Not Provided
Investigators
Principal Investigator: William Audeh, MD Agendia, Inc.
PRS Account Agendia
Verification Date July 2019