FLEX: MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles
Sponsor
Agendia (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03053193
Collaborator
(none)
25,000
112
247.1
223.2
0.9
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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 25,000 patients from 125+ 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 3, 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.
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
25000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)
Actual Study Start Date
:
Apr 28, 2017
Anticipated Primary Completion Date
:
Apr 1, 2037
Anticipated Study Completion Date
:
Dec 1, 2037
Arms and Interventions
| Arm | 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 full genome testing array.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created. [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.
- A shared registry infrastructure to examine smaller groups of interest. [10 years]
Create a shared registry infrastructure to examine smaller groups of interest.
Secondary Outcome Measures
- Subset analyses based on full genome data will be created. [10 years]
Use full genome data to analyze subsets.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHS Grandview | Birmingham | Alabama | United States | 35243 |
| 2 | Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | United States | 85704 |
| 3 | Comprehensive Cancer Center at Desert Regional Medical Center | Palm Springs | California | United States | 92262 |
| 4 | North Valley Breast Clinic | Redding | California | United States | 96001 |
| 5 | UCSF Breast Care Center | San Francisco | California | United States | 94158 |
| 6 | Valley Breast Care | Van Nuys | California | United States | 91405 |
| 7 | Rocky Mountain Cancer Centers | Aurora | Colorado | United States | 80012 |
| 8 | Comprehensive Breast Care of Denver | Denver | Colorado | United States | 80218 |
| 9 | Rocky Mountain Cancer Center - Lakewood | Lakewood | Colorado | United States | 80228 |
| 10 | Vail Health - Shaw Cancer Center | Vail | Colorado | United States | 81658 |
| 11 | St. Mary's Hospital | Waterbury | Connecticut | United States | 06706 |
| 12 | Medical Oncology and Hematology Consultants | Newark | Delaware | United States | 19713 |
| 13 | Breast Specialists of South Florida | Atlantis | Florida | United States | 33462 |
| 14 | JFK Medical Center | Atlantis | Florida | United States | 33462 |
| 15 | Boca Raton Regional Hospital | Boca Raton | Florida | United States | 33428 |
| 16 | Morton Plant Hospital | Clearwater | Florida | United States | 33756 |
| 17 | Halifax Health - Center for Oncology | Daytona Beach | Florida | United States | 32114 |
| 18 | Baptist MD Anderson Cancer Center | Jacksonville | Florida | United States | 32207 |
| 19 | University of Florida - Jacksonville | Jacksonville | Florida | United States | 32224 |
| 20 | St. Vincent Hospital / Mayo Clinic | Jacksonville | Florida | United States | 32256 |
| 21 | Lakeland Regional Cancer Center | Lakeland | Florida | United States | 33805 |
| 22 | Sylvester Comprehensive Cancer Center - University of Miami | Miami | Florida | United States | 33136 |
| 23 | Cancer Care Centers of Brevard | Rockledge | Florida | United States | 32955 |
| 24 | St. Joseph's Hospital - Baycare | Tampa | Florida | United States | 33607 |
| 25 | University of South Florida | Tampa | Florida | United States | 33613 |
| 26 | Winter Haven Hospital | Winter Haven | Florida | United States | 33881 |
| 27 | Phoebe Health | Albany | Georgia | United States | 31701 |
| 28 | Piedmont Cancer Institute | Atlanta | Georgia | United States | 30318 |
| 29 | Emory University - Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
| 30 | Southeast Georgia Health System - Physician Associates | Brunswick | Georgia | United States | 31520 |
| 31 | DeKalb Medical Center | Decatur | Georgia | United States | 30033 |
| 32 | Tift Regional Health System | Tifton | Georgia | United States | 31794 |
| 33 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
| 34 | Alexian Brothers Medical Center | Elk Grove Village | Illinois | United States | 60007 |
| 35 | Saint Alexius Medical Center | Hoffman Estates | Illinois | United States | 60169 |
| 36 | Affiliated Oncologists | Oak Lawn | Illinois | United States | 60453 |
| 37 | Parkview Health | Fort Wayne | Indiana | United States | 46805 |
| 38 | Louisiana State University | New Orleans | Louisiana | United States | 70112 |
| 39 | Mercy Medical Center | Baltimore | Maryland | United States | 21202 |
| 40 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21231 |
| 41 | Maryland Oncology Hematology - Bethesda | Bethesda | Maryland | United States | 20817 |
| 42 | Maryland Oncology Hematology - Brandywine | Brandywine | Maryland | United States | 20613 |
| 43 | Maryland Oncology Hematology - Clinton | Clinton | Maryland | United States | 20735 |
| 44 | Maryland Oncology Hematology, PA | Columbia | Maryland | United States | 21044 |
| 45 | UPMC at Western Maryland Health System | Cumberland | Maryland | United States | 21502 |
| 46 | Frederick Oncology Hematology Associates | Frederick | Maryland | United States | 21702 |
| 47 | Maryland Oncology Hematology - Aquilino Cancer Center | Rockville | Maryland | United States | 20850 |
| 48 | Maryland Oncology Hematology, PA | Silver Spring | Maryland | United States | 20904 |
| 49 | Mercy Medical Center | Springfield | Massachusetts | United States | 01104 |
| 50 | St. John Hospital | Grosse Pointe Woods | Michigan | United States | 48236 |
| 51 | Sparrow Cancer Center | Lansing | Michigan | United States | 48912 |
| 52 | Providence - Providence Park Hospital | Southfield | Michigan | United States | 48075 |
| 53 | Comprehensive Breast Care | Troy | Michigan | United States | 48098 |
| 54 | Minnesota Oncology | Minneapolis | Minnesota | United States | 55404 |
| 55 | Boone Hospital Center | Columbia | Missouri | United States | 65201 |
| 56 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 57 | New York Oncology Hematology | Albany | New York | United States | 12206 |
| 58 | Broome Oncology | Binghamton | New York | United States | 13905 |
| 59 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 60 | Lake Success Oncology / ProHealth Care | Lake Success | New York | United States | 11020 |
| 61 | NYU Winthrop Hospital | Mineola | New York | United States | 11501 |
| 62 | Northwell Health- Northern Westchester Hospital | Mount Kisco | New York | United States | 10549 |
| 63 | Hematology Oncology Center of Rockland at Nyack | Nyack | New York | United States | 10960 |
| 64 | University of Rochester - Pluta Cancer Center | Rochester | New York | United States | 14642 |
| 65 | SUNY Upstate Medical University Hospital | Syracuse | New York | United States | 13210 |
| 66 | Northwell Health- Phelps Hospital | Tarrytown | New York | United States | 10591 |
| 67 | Akron General Medical Center | Akron | Ohio | United States | 44307 |
| 68 | TriHealth Cancer Institutes | Cincinnati | Ohio | United States | 45220 |
| 69 | Cancer Centers of Southwest Oklahoma | Lawton | Oklahoma | United States | 73505 |
| 70 | St. Luke's Hospital | Bethlehem | Pennsylvania | United States | 18015 |
| 71 | Alliance Cancer Specialists | Horsham | Pennsylvania | United States | 19044 |
| 72 | St. Mary Medical Center | Langhorne | Pennsylvania | United States | 19047 |
| 73 | Allegheny Health Network | Pittsburgh | Pennsylvania | United States | 15212 |
| 74 | University of Pittsburgh Medical Centers | Pittsburgh | Pennsylvania | United States | 15213 |
| 75 | Grandview Hospital | Sellersville | Pennsylvania | United States | 18960 |
| 76 | Roper St. Francis Physician Partners - Breast Surgery | Charleston | South Carolina | United States | 29401 |
| 77 | Tidelands Health Coastal Carolina Breast Center | Georgetown | South Carolina | United States | 29442 |
| 78 | West Cancer Center | Germantown | Tennessee | United States | 38138 |
| 79 | Nashville Breast Center | Nashville | Tennessee | United States | 37203 |
| 80 | Texas Oncology - Allen | Allen | Texas | United States | 75013 |
| 81 | Harrington Cancer Center | Amarillo | Texas | United States | 79106 |
| 82 | Texas Oncology - Bedford | Bedford | Texas | United States | 76022 |
| 83 | Texas Oncology - Carrollton | Carrollton | Texas | United States | 75010 |
| 84 | CHRISTUS Spohn Cancer Center | Corpus Christi | Texas | United States | 78404 |
| 85 | Texas Oncology - Methodist Dallas Cancer Center | Dallas | Texas | United States | 75203 |
| 86 | Texas Oncology - Presbyterian | Dallas | Texas | United States | 75231 |
| 87 | Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | United States | 75246 |
| 88 | Texas Oncology - Denton | Denton | Texas | United States | 76210 |
| 89 | Texas Oncology - Flower Mound | Flower Mound | Texas | United States | 75028 |
| 90 | The Center for Cancer and Blood Disorders | Fort Worth | Texas | United States | 76104 |
| 91 | Texas Oncology - Grapevine | Grapevine | Texas | United States | 76051 |
| 92 | Texas Oncology - Memorial City | Houston | Texas | United States | 77024 |
| 93 | Oncology Consultants | Katy | Texas | United States | 77494 |
| 94 | University of Texas Medical Branch | League City | Texas | United States | 77573 |
| 95 | Texas Oncology - Longview | Longview | Texas | United States | 75601 |
| 96 | Texas Tech UHSC - Southwest Cancer Center | Lubbock | Texas | United States | 79430 |
| 97 | Texas Oncology - McKinney | McKinney | Texas | United States | 75071 |
| 98 | Texas Oncology - Plano East | Plano | Texas | United States | 75075 |
| 99 | Texas Oncology - Plano West | Plano | Texas | United States | 95093 |
| 100 | Texas Oncology, PA - Metropolitan | San Antonio | Texas | United States | 78212 |
| 101 | Texas Oncology, PA - Northeast | San Antonio | Texas | United States | 78217 |
| 102 | UT Health Cancer Center | San Antonio | Texas | United States | 78229 |
| 103 | Texas Oncology PA -San Antonio Medical Center | San Antonio | Texas | United States | 78240 |
| 104 | Texas Oncology, PA - Stone Oak | San Antonio | Texas | United States | 78258 |
| 105 | Texas Oncology - Tyler | Tyler | Texas | United States | 75702 |
| 106 | Texas Oncology - Waco | Waco | Texas | United States | 76712 |
| 107 | Texas Oncology - Webster | Webster | Texas | United States | 77584 |
| 108 | Ogden Regional Cancer Center | Ogden | Utah | United States | 84405 |
| 109 | Seattle Cancer Care Alliance | Seattle | Washington | United States | 98109 |
| 110 | Columbia St. Mary's | Milwaukee | Wisconsin | United States | 53211 |
| 111 | University General Hospital Alexandra | Athens | Greece | ||
| 112 | Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
Sponsors and Collaborators
- Agendia
Investigators
- Study Director: William Audeh, MD, Agendia, Inc.
- Principal Investigator: Cynthia X Ma, MD, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Agendia
ClinicalTrials.gov Identifier:
NCT03053193
Other Study ID Numbers:
- FLEX Registry
First Posted:
Feb 15, 2017
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Agendia
Additional relevant MeSH terms: