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Active Clinical Trials

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

Active NCT: 03053193
Allegheny General Hospital
Allegheny General Hospital

Forbes Hospital
Forbes Hospital

Jefferson Hospital
Jefferson Hospital

West Penn Hospital
West Penn Hospital

Wexford Health + Wellness Pavilion
Wexford Health + Wellness Pavilion

Category:
Cancer - Breast
Sponsor: 
Agendia
Contact: 

For more information about this trial, please call 412-330-6151 or send an email to ClinicalTrials@ahn.org.

MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)

Purpose: 

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.

Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Sampling Method:  Non-Probability Sample

Study Population

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.

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