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
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Tracking Information | |||||||
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First Submitted Date | February 9, 2017 | ||||||
First Posted Date | February 15, 2017 | ||||||
Last Update Posted Date | December 22, 2023 | ||||||
Actual Study Start Date | April 28, 2017 | ||||||
Estimated Primary Completion Date | April 2037 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | |||||||
Current Secondary Outcome Measures |
Subset analyses based on full genome data will be created. [ Time Frame: 10 years ] Use full genome data to analyze subsets.
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Original Secondary Outcome Measures |
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) | ||||||
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 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:
FLEX is an observational (phase IV) study. |
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Study Type | Observational [Patient Registry] | ||||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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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.
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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. | ||||||
Condition | Breast Cancer | ||||||
Intervention | 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
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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
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Recruiting | ||||||
Estimated Enrollment |
25000 | ||||||
Original Estimated Enrollment |
2000 | ||||||
Estimated Study Completion Date | December 2037 | ||||||
Estimated Primary Completion Date | April 2037 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts |
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Listed Location Countries | Greece, Israel, 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 |
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IPD Sharing Statement |
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Current Responsible Party | Agendia | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor | Agendia | ||||||
Original Study Sponsor | Same as current | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Agendia | ||||||
Verification Date | December 2023 |