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

August 15, 2025 updated by: Agendia

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 30,000 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Recruiting
        • Thunder Bay Regional Health Sciences Centre
        • Principal Investigator:
          • Olexiy Aseyev
  • Greece
      • Athens, Greece
        • Recruiting
        • University General Hospital Alexandra
        • Contact:
        • Principal Investigator:
          • Spyridon Marinopoulos, MD
  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Contact:
        • Principal Investigator:
          • Amir Sonnenblick
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Completed
        • CHS Grandview
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Phoenix, Arizona, United States, 85006
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Arizona Oncology Associates, PC - HOPE
        • Contact:
        • Principal Investigator:
          • Rachel Swart, MD
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • Adventist Health - Bakersfield
        • Principal Investigator:
          • Nicole Gordon
      • Palm Springs, California, United States, 92262
        • Recruiting
        • Comprehensive Cancer Center at Desert Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Laura Lee, MD
      • Redding, California, United States, 96001
        • Recruiting
        • North Valley Breast Clinic
        • Contact:
          • Ian Grady, MD
          • Phone Number: 530-243-5551
        • Principal Investigator:
          • Ian P Grady, MD
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Breast Care Center
        • Principal Investigator:
          • Rita Mukhtar, MD
        • Principal Investigator:
          • Laura Esserman, MD
        • Contact:
      • Van Nuys, California, United States, 91405
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Cancer Center
        • Principal Investigator:
          • Virginia Borges, MD
        • Contact:
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Rocky Mountain Cancer Centers
        • Contact:
        • Principal Investigator:
          • Sami Diab, MD
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Comprehensive Breast Care of Denver
        • Contact:
        • Principal Investigator:
          • Julie Barone, MD
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Rocky Mountain Cancer Center - Lakewood
        • Principal Investigator:
          • Sami Diab, MD
      • Vail, Colorado, United States, 81658
        • Recruiting
        • Vail Health - Shaw Cancer Center
        • Contact:
        • Principal Investigator:
          • Julie Barone, DO
    • Connecticut
      • Waterbury, Connecticut, United States, 06706
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology and Hematology Consultants
        • Contact:
        • Principal Investigator:
          • Jamal Misleh, MD
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • JFK Medical Center
        • Contact:
        • Principal Investigator:
          • Julian Berrocal, MD
      • Atlantis, Florida, United States, 33462
      • Boca Raton, Florida, United States, 33428
        • Recruiting
        • Boca Raton Regional Hospital
        • Contact:
        • Principal Investigator:
          • Jane Skelton, MD
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Morton Plant Hospital
        • Contact:
        • Principal Investigator:
          • Peter Blumencranz, MD
      • Daytona Beach, Florida, United States, 32114
        • Recruiting
        • Halifax Health - Center for Oncology
        • Contact:
        • Principal Investigator:
          • Ruby Anne Deveras, MD
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Jennifer Crozier, MD
      • Jacksonville, Florida, United States, 32224
        • Completed
        • University of Florida - Jacksonville
      • Jacksonville, Florida, United States, 32256
        • Active, not recruiting
        • St. Vincent Hospital / Mayo Clinic
      • Lakeland, Florida, United States, 33805
        • Recruiting
        • Lakeland Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Madhavi Venigalla, MD
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute at Baptist Health, Inc
        • Principal Investigator:
          • Lauren Carcas
        • Contact:
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center - University of Miami
        • Contact:
        • Principal Investigator:
          • Reshma L Mahtani, MD
      • Rockledge, Florida, United States, 32955
        • Recruiting
        • Cancer Care Centers of Brevard
        • Contact:
        • Principal Investigator:
          • Pavan Kancharla, MD
      • Tampa, Florida, United States, 33613
        • Recruiting
        • University of South Florida
        • Contact:
        • Principal Investigator:
          • Charles Cox, MD
      • Tampa, Florida, United States, 33607
        • Recruiting
        • St. Joseph's Hospital - Baycare
        • Principal Investigator:
          • Robert Gabordi, MD
        • Contact:
      • Winter Haven, Florida, United States, 33881
        • Recruiting
        • Winter Haven Hospital
        • Contact:
        • Principal Investigator:
          • Kamal Sharma, DO
    • Georgia
      • Albany, Georgia, United States, 31701
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Piedmont Cancer Institute
        • Contact:
        • Principal Investigator:
          • Trevor Feinstein, MD
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University - Winship Cancer Institute
        • Contact:
        • Principal Investigator:
          • Cathy Graham, MD
      • Brunswick, Georgia, United States, 31520
        • Recruiting
        • Southeast Georgia Health System - Physician Associates
        • Contact:
        • Principal Investigator:
          • Abraham Cheong, MD
      • Decatur, Georgia, United States, 30033
        • Completed
        • Dekalb Medical Center
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Candler Hospital
        • Principal Investigator:
          • Catherine Ronaghan
      • Tifton, Georgia, United States, 31794
        • Recruiting
        • Tift Regional Health System
        • Contact:
        • Principal Investigator:
          • Apurva Shah, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois at Chicago
        • Contact:
        • Principal Investigator:
          • VK Gadi, MD
      • Elk Grove Village, Illinois, United States, 60007
      • Hoffman Estates, Illinois, United States, 60169
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Affiliated Oncologists
        • Contact:
        • Principal Investigator:
          • Rami Haddad, MD
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Louisiana State University
        • Contact:
        • Principal Investigator:
          • Sarah Thayer, MD
    • Maine
      • Portland, Maine, United States, 04102
        • Recruiting
        • Northern Light Breast Care
        • Principal Investigator:
          • Susan Hoekstra
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Recruiting
        • Luminis Health Center for Cancer & Blood Disorders
        • Principal Investigator:
          • Regina Hampton
      • Baltimore, Maryland, United States, 21202
        • Recruiting
        • Mercy Medical Center
        • Contact:
        • Principal Investigator:
          • David Riseberg, MD
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
        • Principal Investigator:
          • Mehran Habibi, MD
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • Maryland Oncology Hematology - Bethesda
        • Principal Investigator:
          • Carolyn Hendricks, MD
      • Brandywine, Maryland, United States, 20613
        • Recruiting
        • Maryland Oncology Hematology - Brandywine
        • Principal Investigator:
          • Carolyn Hendricks, MD
      • Clinton, Maryland, United States, 20735
        • Recruiting
        • Maryland Oncology Hematology - Clinton
        • Principal Investigator:
          • Carolyn Hendricks, MD
      • Columbia, Maryland, United States, 21044
        • Recruiting
        • Maryland Oncology Hematology, PA
        • Principal Investigator:
          • Carolyn Hendricks, MD
      • Cumberland, Maryland, United States, 21502
        • Recruiting
        • UPMC at Western Maryland Health System
        • Contact:
        • Principal Investigator:
          • Blanche Mavromatis, MD
      • Frederick, Maryland, United States, 21702
        • Recruiting
        • Frederick Oncology Hematology Associates
        • Principal Investigator:
          • Carolyn Hendricks, MD
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • Maryland Oncology Hematology - Aquilino Cancer Center
        • Principal Investigator:
          • Carolyn Hendricks, MD
      • Silver Spring, Maryland, United States, 20904
        • Recruiting
        • Maryland Oncology Hematology, PA
        • Principal Investigator:
          • Carolyn Hendricks, MD
    • Massachusetts
      • Springfield, Massachusetts, United States, 01104
        • Completed
        • Mercy Medical Center
    • Michigan
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • St. John Hospital
        • Contact:
        • Principal Investigator:
          • Carrie Dul, MD
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • Sparrow Cancer Center
        • Contact:
        • Principal Investigator:
          • Gordan Srkalovic, MD
      • Royal Oak, Michigan, United States, 48076
      • Southfield, Michigan, United States, 48075
        • Completed
        • Providence - Providence Park Hospital
      • Troy, Michigan, United States, 48098
        • Recruiting
        • Comprehensive Breast Care
        • Principal Investigator:
          • Eric Brown, MD
        • Contact:
        • Sub-Investigator:
          • Linsey Gold, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Completed
        • Boone Hospital Center
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Cynthia Ma, MD PhD
    • New York
      • Albany, New York, United States, 12206
      • Binghamton, New York, United States, 13905
        • Completed
        • Broome Oncology
      • Buffalo, New York, United States, 14263
      • Lake Success, New York, United States, 11020
        • Completed
        • Lake Success Oncology / ProHealth Care
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Winthrop Hospital
        • Contact:
        • Principal Investigator:
          • Nina D'Abreo, MD
      • Mount Kisco, New York, United States, 10549
        • Recruiting
        • Northwell Health- Northern Westchester Hospital
        • Contact:
        • Principal Investigator:
          • Pond Keleman, MD
      • New York, New York, United States, 10004
        • Recruiting
        • Kings County Hospital
        • Contact:
        • Principal Investigator:
          • Jaime Alberty
      • Nyack, New York, United States, 10960
        • Recruiting
        • Hematology Oncology Center of Rockland at Nyack
        • Contact:
        • Principal Investigator:
          • Sung Ho Lee, MD
      • Rochester, New York, United States, 14642
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Abirami Sivapiragasam, MD
      • Tarrytown, New York, United States, 10591
        • Recruiting
        • Northwell Health- Phelps Hospital
        • Contact:
        • Principal Investigator:
          • Pond Kelemen
    • Ohio
      • Akron, Ohio, United States, 44307
        • Recruiting
        • Akron General Medical Center
        • Contact:
        • Principal Investigator:
          • Esther Rehmus
      • Cincinnati, Ohio, United States, 45236
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • TriHealth Cancer Institutes
        • Contact:
        • Principal Investigator:
          • Apurva Mehta, MD
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Completed
        • Cancer Centers of Southwest Oklahoma
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Willamette Valley Cancer Institute and Research Center
        • Contact:
        • Principal Investigator:
          • Benjamin Cho, MD
      • Portland, Oregon, United States, 97239
        • Completed
        • Oregon Health Sciences University
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Legacy Good Samaritan Medical Center
        • Principal Investigator:
          • Nathalie Johnson
        • Contact:
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St. Luke's Hospital
        • Contact:
        • Principal Investigator:
          • Lee Riley, MD
      • Broomall, Pennsylvania, United States, 19008
        • Recruiting
        • Consultants In Medical Oncology and Hematology, P.C.
        • Contact:
        • Principal Investigator:
          • Laura Austin
      • Horsham, Pennsylvania, United States, 19044
      • Langhorne, Pennsylvania, United States, 19047
        • Terminated
        • St. Mary Medical Center
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network
        • Contact:
        • Principal Investigator:
          • Diane Buchbarker, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Centers
        • Contact:
        • Principal Investigator:
          • Adam Brufsky, MD, PhD
      • Sellersville, Pennsylvania, United States, 18960
        • Completed
        • Grandview Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Recruiting
        • Roper St. Francis Physician Partners - Breast Surgery
        • Contact:
        • Principal Investigator:
          • Megan Baker, MD
      • Georgetown, South Carolina, United States, 29442
        • Recruiting
        • Tidelands Health Coastal Carolina Breast Center
        • Contact:
        • Principal Investigator:
          • Angela Mislowsky, MD
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • West Cancer Center
        • Principal Investigator:
          • Richard Fine, MD
        • Contact:
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Nashville Breast Center
        • Principal Investigator:
          • Pat W Whitworth, MD
        • Contact:
          • Kristie Appleton
          • Phone Number: 615-620-5535
    • Texas
      • Allen, Texas, United States, 75013
      • Amarillo, Texas, United States, 79106
        • Completed
        • Harrington Cancer Center
      • Austin, Texas, United States, 78731
      • Bedford, Texas, United States, 76022
      • Carrollton, Texas, United States, 75010
      • Corpus Christi, Texas, United States, 78404
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
        • Contact:
        • Principal Investigator:
          • Joyce O'Shaughnessy, MD
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Oncology - Presbyterian
        • Principal Investigator:
          • Kristi McIntyre, MD
      • Dallas, Texas, United States, 75203
        • Completed
        • Texas Oncology - Methodist Dallas Cancer Center
      • Denton, Texas, United States, 76210
      • Flower Mound, Texas, United States, 75028
      • Fort Worth, Texas, United States, 76104
        • Completed
        • The Center for Cancer and Blood Disorders
      • Grapevine, Texas, United States, 76051
      • Houston, Texas, United States, 77024
        • Recruiting
        • Texas Oncology - Memorial City
        • Contact:
        • Principal Investigator:
          • Michelina Cairo, MD
      • Houston, Texas, United States, 77070
        • Recruiting
        • Texas Oncology Willowbrook
        • Contact:
          • Catherine Barter
        • Principal Investigator:
          • John Thachil
      • Katy, Texas, United States, 77494
        • Completed
        • Oncology Consultants
      • League City, Texas, United States, 77573
        • Recruiting
        • University of Texas Medical Branch
        • Contact:
        • Principal Investigator:
          • V. Suzanne Klimberg, MD
      • Longview, Texas, United States, 75601
        • Recruiting
        • Texas Oncology - Longview
        • Principal Investigator:
          • Svetislava Vukelja, MD
      • Lubbock, Texas, United States, 79430
        • Recruiting
        • Texas Tech UHSC - Southwest Cancer Center
        • Contact:
        • Principal Investigator:
          • Rakhshanda Layeequr-Rahman, MD
      • McKinney, Texas, United States, 75071
        • Recruiting
        • Texas Oncology - McKinney
        • Contact:
        • Principal Investigator:
          • Monte Jones, MD
      • Plano, Texas, United States, 75075
        • Recruiting
        • Texas Oncology - Plano East
        • Principal Investigator:
          • Christopher Stokoe, MD
      • Plano, Texas, United States, 95093
        • Recruiting
        • Texas Oncology - Plano West
        • Principal Investigator:
          • Philip Kovoor, MD
        • Contact:
      • San Antonio, Texas, United States, 78212
        • Recruiting
        • Texas Oncology, PA - Metropolitan
        • Principal Investigator:
          • Emmalind Aponte, MD
      • San Antonio, Texas, United States, 78217
        • Recruiting
        • Texas Oncology, PA - Northeast
        • Principal Investigator:
          • Emmalind Aponte, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Virginia Kaklamani, MD
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology PA -San Antonio Medical Center
        • Principal Investigator:
          • Emmalind Aponte, MD
      • San Antonio, Texas, United States, 78258
        • Recruiting
        • Texas Oncology, PA - Stone Oak
        • Principal Investigator:
          • Emmalind Aponte, MD
      • Sugar Land, Texas, United States, 77479
      • Tyler, Texas, United States, 75702
        • Recruiting
        • Texas Oncology - Tyler
        • Principal Investigator:
          • Svetislava Vukelja, MD
      • Waco, Texas, United States, 76712
        • Recruiting
        • Texas Oncology - Waco
        • Contact:
        • Principal Investigator:
          • Carlos Encarnacion, MD
      • Webster, Texas, United States, 77584
        • Recruiting
        • Texas Oncology - Webster
        • Principal Investigator:
          • Dhatri Kodali, MD
    • Utah
    • Washington
      • Mount Vernon, Washington, United States, 98273
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute
        • Contact:
        • Principal Investigator:
          • Fengting Yan, MD
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Seattle Cancer Care Alliance
        • Contact:
        • Principal Investigator:
          • Natasha Hunter, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • Recruiting
        • Columbia St. Mary's
        • Contact:
        • Principal Investigator:
          • Varsha Shah, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study population will include patients with stage I, II, or 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • MammaPrint, BluePrint

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10 years
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.
10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subset analyses based on full genome data will be created.
Time Frame: 10 years
Use full genome data to analyze subsets.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Agendia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: William Audeh, MD, Agendia, Inc.
  • Principal Investigator: Joyce O'Shaughnessy, MD, Texas Oncology - Baylor Charles A. Sammons Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2037

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2037

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FLEX Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Dietary Supplements

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