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

Use our guide to learn which trials are right for you!

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