NCT03053193 MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles
| NCT ID | NCT03053193 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Agendia |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 30,000 participants |
| Start Date | 2017-04-28 |
| Primary Completion | 2037-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30,000 participants in total. It began in 2017-04-28 with a primary completion date of 2037-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
William Audeh, MD
STUDY DIRECTOR
Agendia, Inc.
Frequently Asked Questions
Who can join the NCT03053193 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03053193 currently recruiting?
Yes, NCT03053193 is actively recruiting participants. Contact the research team at michelle.landon@agendia.com for enrollment information.
Where is the NCT03053193 trial being conducted?
This trial is being conducted at Birmingham, United States, Anchorage, United States, Phoenix, United States, Tucson, United States and 11 additional locations.
Who is sponsoring the NCT03053193 clinical trial?
NCT03053193 is sponsored by Agendia. The principal investigator is William Audeh, MD at Agendia, Inc.. The trial plans to enroll 30,000 participants.
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