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 : September 9, 2020
|Condition or disease||Intervention/treatment|
|Breast Cancer||Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing|
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.
- 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]|
|Estimated Enrollment :||10000 participants|
|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 Registry)|
|Actual Study Start Date :||April 28, 2017|
|Estimated Primary Completion Date :||April 2030|
|Estimated Study Completion Date :||December 2030|
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 DiscoverPrint testing array.
Other Name: MammaPrint, BluePrint, DiscoverPrint
- 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.
- 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
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
|Contact: Sarah Untch, MSemail@example.com|
|Study Director:||William Audeh, MD||Agendia, Inc.|
|Principal Investigator:||Cynthia X Ma, MD||Washington University School of Medicine|