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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 : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Agendia

February 9, 2017
February 15, 2017
January 10, 2019
April 28, 2017
April 2027   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT03053193 on ClinicalTrials.gov Archive Site
Subset analyses based on full genome data will be created. [ Time Frame: 10 years ]
Same as current
Not Provided
Not Provided
 
MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles
MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)
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.

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.

Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
10 Years
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.
Non-Probability Sample
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.
Breast Cancer
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
2000
December 2027
April 2027   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Sarah Untch, MS 412-770-6906 sarah.untch@agendia.com
United States
 
 
NCT03053193
FLEX Registry
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Agendia
Agendia
Not Provided
Not Provided
Agendia
January 2019