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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03053193
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Agendia

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.

Condition or disease Intervention/treatment
Breast Cancer Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing

Detailed 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)
Actual Study Start Date : April 28, 2017
Estimated Primary Completion Date : April 2027
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MammaPrint and BluePrint testing
All patients will receive MammaPrint and BluePrint testing using the full-genome testing data chip. Treatment will be at the discretion of the physician while adhering to NCCN guidelines.
Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing
Agendia will run MammaPrint and BluePrint tests using the DiscoverPrint testing array.
Other Name: MammaPrint, BluePrint, DiscoverPrint




Primary Outcome Measures :
  1. A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created. [ Time Frame: 10 years ]
    Create a large scale registry of full genome expression data with clinical data to investigate possible new gene associations with prognostic or predictive value.

  2. A shared registry infrastructure to examine smaller groups of interest. [ Time Frame: 10 years ]
    Create a shared registry infrastructure to examine smaller groups of interest.


Secondary Outcome Measures :
  1. Subset analyses based on full genome data will be created. [ Time Frame: 10 years ]
    Use full genome data to analyze subsets.


Biospecimen Retention:   Samples With DNA
Tumor tissue acquired as part of a standard of care biopsy or surgical procedure will be sent to Agendia for testing.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053193


Contacts
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Contact: Sarah Untch, MS 412-770-6906 sarah.untch@agendia.com

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Locations
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United States, Arizona
Arizona Oncology Associates, PC - HOPE Recruiting
Tucson, Arizona, United States, 85704
Contact: Julie Klinker       julie.klinker@usoncology.com   
Principal Investigator: Rachel Swart, MD         
United States, California
Comprehensive Cancer Center at Desert Regional Medical Center Recruiting
Palm Springs, California, United States, 92262
Contact: Claudia Fortiche       claudia.fortiche@tenethealth.com   
Principal Investigator: Laura Lee, MD         
North Valley Breast Clinic Recruiting
Redding, California, United States, 96001
Contact: Ian Grady, MD    530-243-5551      
Principal Investigator: Ian P Grady, MD         
Valley Breast Care Recruiting
Van Nuys, California, United States, 91405
Contact: James Dunham       james@valleybreastcare.org   
Principal Investigator: Thomas Lomis, MD         
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Aurora, Colorado, United States, 80012
Principal Investigator: Sami Diab, MD         
Comprehensive Breast Care of Denver Recruiting
Denver, Colorado, United States, 80218
Contact: Joseph Ruybal, MA       Joseph.Ruybal@sclhs.net   
Principal Investigator: Julie Barone, MD         
Rocky Mountain Cancer Center - Lakewood Recruiting
Lakewood, Colorado, United States, 80228
Principal Investigator: Sami Diab, MD         
United States, Connecticut
St. Mary's Hospital Recruiting
Waterbury, Connecticut, United States, 06706
Contact: Jessica Bello       Jessica.Bello@stfranciscare.org   
Principal Investigator: Beth Sieling, MD         
United States, Delaware
Medical Oncology and Hematology Consultants Recruiting
Newark, Delaware, United States, 19713
Principal Investigator: Jamal Misleh, MD         
United States, Florida
JFK Medical Center Recruiting
Atlantis, Florida, United States, 33462
Contact: Tonnica Sasanas, RN, BSN    561-548-1877    Tonnica.Sasanas@hcahealthcare.com   
Principal Investigator: June Lee, MD         
Boca Raton Regional Hospital Recruiting
Boca Raton, Florida, United States, 33428
Contact: Maggie Szymczak       mszymczak@brrh.com   
Principal Investigator: Jane Skelton, MD         
Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
Contact: Debra Ellis, RN    727-461-8526    Debra.Ellis@Baycare.org   
Principal Investigator: Peter Blumencranz, MD         
Halifax Health - Center for Oncology Recruiting
Daytona Beach, Florida, United States, 32114
Contact: Deborah Reynolds       debbie.reynolds@halifax.org   
Principal Investigator: Ruby Anne Deveras, MD         
Baptist MD Anderson Cancer Center Recruiting
Jacksonville, Florida, United States, 32207
Contact: Mila Shteyn, MA    904-202-7072      
Principal Investigator: Jennifer Crozier, MD         
Lakeland Regional Cancer Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Rebecca Delph       Rebecca.Delph@myLRH.org   
Principal Investigator: Madhavi Venigalla, MD         
Cancer Care Centers of Brevard Recruiting
Rockledge, Florida, United States, 32955
Principal Investigator: Pavan Kancharla, MD         
University of South Florida Recruiting
Tampa, Florida, United States, 33620
Principal Investigator: Charles Cox, MD         
Winter Haven Hospital Recruiting
Winter Haven, Florida, United States, 33881
Contact: Jan Bauer, RN    863-293-1121 ext 5872    Janet.Bauer@baycare.org   
Principal Investigator: Kamal Sharma, DO         
United States, Georgia
Piedmont Cancer Institute Recruiting
Atlanta, Georgia, United States, 30318
Principal Investigator: Trevor Feinstein, MD         
Southeast Georgia Health System - Physician Associates Recruiting
Brunswick, Georgia, United States, 31520
Contact: Gwen Gratto-Cox       ggratto@sghs.org   
Principal Investigator: Antonio Moran, Jr., MD         
DeKalb Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: Ruthie Sweat       Ruthie.Sweat@dekalbmedical.org   
Principal Investigator: Jayanthi Srinivasiah, MD         
Tift Regional Health System Recruiting
Tifton, Georgia, United States, 31794
Contact: Jodie Davis, RN    229-353-3730    Jodie.Davis@tiftregional.com   
Principal Investigator: Apurva Shah, MD         
United States, Illinois
John H. Stroger Jr. Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Julie Wecsler, MD         
Alexian Brothers Medical Center Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Lauren Niklinski       Lauren.Niklinski@AMITAhealth.org   
Principal Investigator: Robert Maganini, MD         
Saint Alexius Medical Center Recruiting
Hoffman Estates, Illinois, United States, 60169
Contact: Lauren Niklinski       Lauren.Niklinski@AMITAhealth.org   
Principal Investigator: Robert Maganini, MD         
United States, Louisiana
Louisiana State University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Camille Fournet       mfourn@lsuhsc.edu   
Principal Investigator: Lucio Miele, MD, PhD         
Sub-Investigator: Agustin Garcia, MD         
Sub-Investigator: Adam Riker, MD         
United States, Maryland
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Contact: Lisa McConnell       lmcconnell@mdmercy.com   
Principal Investigator: David Riseberg, MD         
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21231
Contact: Catherine Klein       cklein2@jhmi.edu   
Principal Investigator: Mehran Habibi, MD         
Maryland Oncology Hematology - Bethesda Recruiting
Bethesda, Maryland, United States, 20817
Principal Investigator: Carolyn Hendricks, MD         
Maryland Oncology Hematology - Brandywine Recruiting
Brandywine, Maryland, United States, 20613
Principal Investigator: Carolyn Hendricks, MD         
Maryland Oncology Hematology - Clinton Recruiting
Clinton, Maryland, United States, 20735
Principal Investigator: Carolyn Hendricks, MD         
Maryland Oncology Hematology, PA Recruiting
Columbia, Maryland, United States, 21044
Principal Investigator: Carolyn Hendricks, MD         
Western Maryland Health System Recruiting
Cumberland, Maryland, United States, 21502
Contact: Mildred Seletyn       mseletyn@wmhs.com   
Principal Investigator: Blanche Mavromatis, MD         
Frederick Oncology Hematology Associates Recruiting
Frederick, Maryland, United States, 21702
Principal Investigator: Carolyn Hendricks, MD         
Maryland Oncology Hematology - Aquilino Cancer Center Recruiting
Rockville, Maryland, United States, 20850
Principal Investigator: Carolyn Hendricks, MD         
Maryland Oncology Hematology, PA Recruiting
Silver Spring, Maryland, United States, 20904
Principal Investigator: Carolyn Hendricks, MD         
United States, Massachusetts
Mercy Medical Center Recruiting
Springfield, Massachusetts, United States, 01104
Contact: Beverly Little-Ouellette       Beverly.Little-Ouellette@sphs.com   
Principal Investigator: Lisa Planeta, MD         
United States, Michigan
St. John Hospital Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Margaret van der Veen, RN    313-343-4657    Margaret.Vanderveen@ascension.org   
Principal Investigator: Carrie Dul, MD         
Sparrow Cancer Center Recruiting
Lansing, Michigan, United States, 48912
Contact: Harsha Trivedi       harsha.trivedi@sparrow.org   
Principal Investigator: Gordan Srkalovic, MD         
Providence - Providence Park Hospital Recruiting
Southfield, Michigan, United States, 48075
Contact: Karen Fife, OCN, CCRP    248-849-5332    Karen.Fife@ascension.org   
Principal Investigator: Howard Terebelo, MD         
United States, Minnesota
Minnesota Oncology Recruiting
Minneapolis, Minnesota, United States, 55404
Principal Investigator: Michaela Tsai, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Mary Lynne Tarquini       MaryLynne.Tarquini@RoswellPark.org   
Principal Investigator: Ellis Levine, MD         
Ashikari Breast Center Recruiting
Dobbs Ferry, New York, United States, 10522
Contact: Julissa Cruz       jcruz@riversidehealth.org   
Principal Investigator: Pond Keleman, MD         
NYU Winthrop Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Johanna Lee, RN    516-663-1237    Johanna.Lee@nyulangone.org   
Principal Investigator: Nina D'Abreo, MD         
Hematology Oncology Center of Rockland at Nyack Recruiting
Nyack, New York, United States, 10960
Contact: Marion VanWoudenberg       research@highlandmedicalpc.com   
Principal Investigator: Sung Ho Lee, MD         
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Erinn McDowell       McDowellE@upstate.edu   
Principal Investigator: Abirami Sivapiragasam, MD         
United States, Ohio
Akron General Medical Center Recruiting
Akron, Ohio, United States, 44307
Contact: Michael McNeal       michael.mcneal@akrongeneral.org   
Principal Investigator: Esther Rehmus         
TriHealth Cancer Institutes Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Nancy Firsich, RN, BSN    513-865-5569    nancy_firsich@trihealth.com   
Principal Investigator: Apurva Mehta, MD         
United States, Oklahoma
Cancer Centers of Southwest Oklahoma Recruiting
Lawton, Oklahoma, United States, 73505
Contact: Susie McCoy       susie.mccoy@ccswok.org   
Principal Investigator: Jose Najera, MD         
United States, Pennsylvania
St. Luke's Hospital Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Carol Kachmarsky       Carol.Kachmarsky@sluhn.org   
Principal Investigator: Lee Riley, MD         
St. Mary Medical Center Recruiting
Langhorne, Pennsylvania, United States, 19047
Contact: Christine Armetta, RN, BSN, MBA    215-710-5328    carmetta@stmaryhealthcare.org   
Principal Investigator: Robert Reilly, DO         
Yolanda G. Barco Oncology Institute Recruiting
Meadville, Pennsylvania, United States, 16335
Contact: Amy Przepiora       aprzepiora1@mmchs.org   
Principal Investigator: Calvin Han, MD         
University of Pittsburgh Medical Centers Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Christine Thomas       thomascr@upmc.edu   
Principal Investigator: Adam Brufsky, MD, PhD         
Grandview Hospital Recruiting
Sellersville, Pennsylvania, United States, 18960
Contact: Pat Parsons       pparsons@gvh.org   
Principal Investigator: Monique Gary, MD         
United States, South Carolina
Roper St. Francis Physician Partners - Breast Surgery Recruiting
Charleston, South Carolina, United States, 29401
Contact: Courtney O'Neill Roldan, MHA       courtney.oneill@rsfh.com   
Principal Investigator: Paul Baron, MD         
Tidelands Health Coastal Carolina Breast Center Recruiting
Georgetown, South Carolina, United States, 29442
Contact: Barbara Roe       broe@tidelandshealth.org   
Principal Investigator: Angela Mislowsky, MD         
United States, Tennessee
Nashville Breast Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Kristie Appleton    615-620-5535      
Principal Investigator: Pat W Whitworth, MD         
United States, Texas
Texas Oncology - Allen Recruiting
Allen, Texas, United States, 75013
Contact: Tejvir Anand       tejvir.anand@usoncology.com   
Principal Investigator: Monte Jones, MD         
Harrington Cancer Center Recruiting
Amarillo, Texas, United States, 79106
Contact: Gina Cravey       gcravey@harringtoncc.org   
Principal Investigator: Brian Pruitt, MD         
Texas Oncology - Bedford Recruiting
Bedford, Texas, United States, 76022
Contact: Sandy Mathews       sandy.mathews@usoncology.com   
Principal Investigator: Lea Krekow, MD         
Texas Oncology - Carrollton Recruiting
Carrollton, Texas, United States, 75010
Contact: Whitney Koracin       whitney.koracin@usoncology.com   
Principal Investigator: Vibha Thomas, MD         
CHRISTUS Spohn Cancer Center Recruiting
Corpus Christi, Texas, United States, 78404
Contact: Polly Mock       polly.mock@christushealth.org   
Principal Investigator: Shantan Reddy, MD         
Texas Oncology - Methodist Dallas Cancer Center Recruiting
Dallas, Texas, United States, 75203
Principal Investigator: Atisha Manhas, MD         
Texas Oncology - Presbyterian Recruiting
Dallas, Texas, United States, 75231
Principal Investigator: Kristi McIntyre, MD         
Texas Oncology-Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Teinette Wells       teinette.wells@usoncology.com   
Principal Investigator: Joyce O'Shaughnessy, MD         
Texas Oncology - Denton Recruiting
Denton, Texas, United States, 76210
Principal Investigator: Sharad Jain, MD         
Texas Oncology - Flower Mound Recruiting
Flower Mound, Texas, United States, 75028
Contact: Whitney Koracin       whitney.koracin@usoncology.com   
Principal Investigator: Vibha Thomas, MD         
The Center for Cancer and Blood Disorders Recruiting
Fort Worth, Texas, United States, 76104
Contact: Melissa Pool       mpool@txcc.com   
Principal Investigator: Robyn Young, MD         
Texas Oncology - Grapevine Recruiting
Grapevine, Texas, United States, 76051
Contact: Sandy Mathews       sandy.mathews@usoncology.com   
Principal Investigator: Lea Krekow, MD         
Oncology Consultants Northwest Recruiting
Houston, Texas, United States, 77008
Contact: Laura Guerra       lguerra@oncologyconsultants.com   
Principal Investigator: Julio Peguero, MD         
Oncology Consultants - Gessner Recruiting
Houston, Texas, United States, 77024
Contact: Laura Guerra       lguerra@oncologyconsultants.com   
Principal Investigator: Julio Peguero, MD         
Oncology Consultants - Memorial City Recruiting
Houston, Texas, United States, 77024
Contact: Laura Guerra       lguerra@oncologyconsultants.com   
Principal Investigator: Julio Peguero, MD         
Texas Oncology - Memorial City Recruiting
Houston, Texas, United States, 77024
Contact: Rowena Martinez       rowena.martinez@usoncology.com   
Principal Investigator: Michelina Cairo, MD         
Oncology Consultants Willowbrook Recruiting
Houston, Texas, United States, 77071
Contact: Laura Guerra       lguerra@oncologyconsultants.com   
Principal Investigator: Julio Peguero, MD         
Oncology Consultants - Katy Recruiting
Katy, Texas, United States, 77494
Contact: Laura Guerra       lguerra@oncologyconsultants.com   
Principal Investigator: Julio Peguero, MD         
Texas Oncology - Longview Recruiting
Longview, Texas, United States, 75601
Principal Investigator: Svetislava Vukelja, MD         
Texas Tech UHSC - Southwest Cancer Center Recruiting
Lubbock, Texas, United States, 79430
Contact: Melanie Bisbee       melanie.bisbee@umchealthsystem.com   
Principal Investigator: Rakhshanda Layeequr-Rahman, MD         
Texas Oncology - McKinney Recruiting
McKinney, Texas, United States, 75071
Contact: Tejvir Anand       tejvir.anand@usoncology.com   
Principal Investigator: Monte Jones, MD         
Oncology Consultants - Pearland Recruiting
Pearland, Texas, United States, 77584
Contact: Laura Guerra       lguerra@oncologyconsultants.com   
Principal Investigator: Julio Peguero, MD         
Texas Oncology - Plano East Recruiting
Plano, Texas, United States, 75075
Principal Investigator: Christopher Stokoe, MD         
Texas Oncology - Plano West Recruiting
Plano, Texas, United States, 95093
Contact: Tejvir Anand       tejvir.anand@usoncology.com   
Principal Investigator: Philip Kovoor, MD         
Texas Oncology, PA - Metropolitan Recruiting
San Antonio, Texas, United States, 78212
Principal Investigator: Emmalind Aponte, MD         
Texas Oncology, PA - Northeast Recruiting
San Antonio, Texas, United States, 78217
Principal Investigator: Emmalind Aponte, MD         
UT Health Cancer Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Lacey McClure       McClureL1@uthscsa.edu   
Principal Investigator: Virginia Kaklamani, MD         
Texas Oncology PA -San Antonio Medical Center Recruiting
San Antonio, Texas, United States, 78240
Principal Investigator: Emmalind Aponte, MD         
Texas Oncology, PA - Stone Oak Recruiting
San Antonio, Texas, United States, 78258
Principal Investigator: Emmalind Aponte, MD         
Oncology Consultants - Sugar Land Recruiting
Sugar Land, Texas, United States, 77479
Contact: Laura Guerra       lguerra@oncologyconsultants.com   
Principal Investigator: Julio Peguero, MD         
Texas Oncology - Tyler Recruiting
Tyler, Texas, United States, 75702
Principal Investigator: Svetislava Vukelja, MD         
Texas Oncology - Waco Recruiting
Waco, Texas, United States, 76712
Contact: Laura Fonseca       laura.fonseca@usoncology.com   
Principal Investigator: Carlos Encarnacion, MD         
Texas Oncology - Webster Recruiting
Webster, Texas, United States, 77584
Principal Investigator: Dhatri Kodali, MD         
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Obsy Tadesse       otadesse@seattlecca.org   
Principal Investigator: Vijayakrishna Gadi, MD         
Sponsors and Collaborators
Agendia
Investigators
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Principal Investigator: William Audeh, MD Agendia, Inc.

Additional Information:

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Responsible Party: Agendia
ClinicalTrials.gov Identifier: NCT03053193     History of Changes
Other Study ID Numbers: FLEX Registry
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Agendia:
breast cancer
stage I
stage II
stage III
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases