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

  • STATUS
    Recruiting
  • End date
    Dec 16, 2030
  • participants needed
    10000
  • sponsor
    Agendia
Updated on 16 September 2020
Investigator
Sarah Untch, MS
Primary Contact
Maryland Oncology Hematology, PA (8.7 mi away) Contact
+111 other location

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.

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.

Details
Treatment MammaPrint, BluePrint, and Full-Genome Testing
Clinical Study IdentifierNCT03053193
SponsorAgendia
Last Modified on16 September 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Breast Cancer?
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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