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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:April 28, 2017
End Date:December 2027
Contact:Sarah Untch, MS
Email:sarah.untch@agendia.com
Phone:412-770-6906

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

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.

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.

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
We found this trial at
49
sites
Denver, Colorado 80218
Principal Investigator: Julie Barone, MD
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Ellis Levine, MD
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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3525
Lakeland, Florida 33805
Principal Investigator: Madhavi Venigalla, MD
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Lakeland, FL
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Principal Investigator: Esther Rehmus
Akron General Medical Center It
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Akron, OH
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1105 North Central Expressway
Allen, Texas 75013
Principal Investigator: Monte Jones, MD
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Allen, TX
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Atlanta, Georgia 30318
Principal Investigator: Trevor Feinstein, MD
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Atlanta, GA
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Atlantis, Florida 33462
Principal Investigator: June Lee, MD
Phone: 561-548-1877
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Atlantis, FL
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Principal Investigator: David Riseberg, MD
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Bedford, Texas 76022
Principal Investigator: Lea Krekow, MD
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Bethlehem, Pennsylvania 18015
Principal Investigator: Lee Riley, MD
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Carrollton, Texas 75010
Principal Investigator: Vibha Thomas, MD
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2145 Henry Tecklenburg Drive
Charleston, South Carolina 29401
Principal Investigator: Paul Baron, MD
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Cincinnati, Ohio 45220
Principal Investigator: Apurva Mehta, MD
Phone: 513-865-5569
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Clearwater, Florida 33756
Principal Investigator: Peter Blumencranz, MD
Phone: 727-461-8526
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Corpus Christi, Texas 78405
Principal Investigator: Shantan Reddy, MD
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Cumberland, Maryland 21502
Principal Investigator: Blanche Mavromatis, MD
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Dallas, Texas 75246
Principal Investigator: Joyce O'Shaughnessy, MD
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Decatur, Georgia 30033
Principal Investigator: Jayanthi Srinivasiah, MD
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128 Ashford Avenue
Dobbs Ferry, New York 10522
Principal Investigator: Pond Keleman, MD
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Flower Mound, Texas 75028
Principal Investigator: Vibha Thomas, MD
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Fort Worth, Texas 76104
Principal Investigator: Robyn Young, MD
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Georgetown, South Carolina 29442
Principal Investigator: Angela Mislowsky, MD
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Grapevine, Texas 76051
Principal Investigator: Lea Krekow, MD
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Grosse Pointe Woods, Michigan 48236
Principal Investigator: Carrie Dul, MD
Phone: 313-343-4657
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Houston, Texas 77024
Principal Investigator: Michelina Cairo, MD
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Jacksonville, Florida 32207
Principal Investigator: Jennifer Crozier, MD
Phone: 904-202-7072
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Langhorne, Pennsylvania 19047
Principal Investigator: Robert Reilly, DO
Phone: 215-710-5328
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Lansing, Michigan 48912
Principal Investigator: Gordan Srkalovic, MD
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Lawton, Oklahoma 73505
Principal Investigator: Jose Najera, MD
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5236 West University Drive
McKinney, Texas 75071
Principal Investigator: Monte Jones, MD
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Meadville, Pennsylvania 16335
Principal Investigator: Calvin Han, MD
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259 1st Street
Mineola, New York 11501
Principal Investigator: Nina D'Abreo, MD
Phone: 516-663-1237
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Nashville, Tennessee 37203
Principal Investigator: Pat W Whitworth, MD
Phone: 615-620-5535
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New Orleans, Louisiana 70112
Principal Investigator: Lucio Miele, MD, PhD
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160 North Midland Avenue
Nyack, New York 10960
Principal Investigator: Sung Ho Lee, MD
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Palm Springs, California 92262
Principal Investigator: Laura Lee, MD
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Pittsburgh, Pennsylvania 15261
Principal Investigator: Adam Brufsky, MD, PhD
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Plano, Texas 75093
Principal Investigator: Philip Kovoor, MD
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Redding, California 96001
Principal Investigator: Ian P Grady, MD
Phone: 530-243-5551
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Saint Louis, Missouri 63110
Principal Investigator: Yifan Tu, MD
Phone: 314-268-7058
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San Antonio, Texas 78229
Principal Investigator: Virginia Kaklamani, MD
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16001 West Nine Mile Road
Southfield, Michigan 48075
Principal Investigator: Howard Terebelo, MD
Phone: 248-849-5332
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Springfield, Massachusetts 01102
Principal Investigator: Lisa Planeta, MD
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Tifton, Georgia 31794
Principal Investigator: Apurva Shah, MD
Phone: 229-353-3730
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Tucson, Arizona 85704
Principal Investigator: Rachel Swart, MD
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12697 East 51st Street South
Tulsa, Oklahoma 74146
Principal Investigator: Melinda Dunlap, MD
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15211 Vanowen Street
Van Nuys, California 91405
Principal Investigator: Thomas Lomis, MD
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Waco, Texas 76712
Principal Investigator: Carlos Encarnacion, MD
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Winter Haven, Florida 33881
Principal Investigator: Kamal Sharma, DO
Phone: 863-293-1121
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