The PREDICT Registry: (PREDICT)

April 14, 2026 updated by: PreludeDx

A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients With DCIS Following Breast Conserving Therapy

This is a prospective, non-interventional (observational) cohort study conducted within the medical network of the participating investigators and institutions. Patients meeting the eligibility criteria (see below) will be eligible for participation and the investigators will obtain written informed consent. A central Institutional Review Board (IRB), WCG IRB, will approve the protocol and each participating institution.

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

After a diagnosis of DCIS, the most representative tissue block (or 10 sections mounted on charged slides cut at 3-4 microns) will be sent to PreludeDx for DCISionRT. The most representative specimen should be selected from tissue collected via direct tumor biopsy (either core needle or excisional biopsy) as part of routine patient care. Patients must be enrolled in the study and the enrollment and pre-testing data forms must be completed and submitted before the DCISionRT results are reported. Then, after review of the DCISionRT results, the investigators complete and submit the post-testing data form. The patient may then be followed for up to 10 years (or until death) with completion of 5- and 10-year follow-up forms.

All study data will be stored in an encrypted, HIPAA-compliant database maintained by the coordinating center. Each consented patient will be assigned a unique Study ID number. Study personnel at each institution will maintain an electronic key to link the Study IDs of its own patients to the patients' local medical record number. All personal health information (PHI) will remain at the local institution and only de-identified data will be uploaded to the national registry. No genetic test results that may be used to identify the patient will be included in the database.

This study is designed to assess the magnitude of and conditions impacting physician treatment recommendations based on the DCISionRT test results, assessing patient preference, and within various clinicopathologic subgroups. This will also be the largest prospective determination of IBR outcomes with DCISionRT test result correlates to date.

Part I of the PREDICT Registry recently completed enrollment of 2,500 subjects for whom DCISionRT results had been reported using the original test protocol that classified patients into two risk groups, Low Risk and Elevated Risk.64

Part II of the PREDICT Registry will enroll up to an additional 3,000 subjects from 15 to 30 sites within the United States with each site enrolling between 100 and 300 patients. DCISionRT results will be reported using the updated test protocol that classifies patients into three risk groups, Low Risk, Elevated Risk and Residual Risk. Part II study procedures will be conducted exactly the same as Part I, except that further patient demographics and treatment preference, treatment recommendation details, and patient upstaging will be collected. Additional questions will be asked to determine how physicians use the Residual Risk group classification to make treatment decisions. De-identified imaging data may also be collected, and de-identified patient tissue samples may be collected after 1 year.

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.
3000

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 Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Arizona Center for Cancer Care
        • Contact:
        • Sub-Investigator:
          • Christopher Biggs, MD
        • Sub-Investigator:
          • Jason Samuelian, DO
        • Sub-Investigator:
          • Scott Tannehill, MD
        • Sub-Investigator:
          • Steven Sckolnik, MD
        • Sub-Investigator:
          • Kimberli Cox, MD
        • Sub-Investigator:
          • Justin Famoso, MD
        • Sub-Investigator:
          • Ashley Albert, MD
        • Sub-Investigator:
          • Sara Zakem, MD
        • Contact:
        • Principal Investigator:
          • Anushka Patel, MD
        • Sub-Investigator:
          • Daniel Reed, DO
        • Sub-Investigator:
          • Sommer Gunia, DO
        • Sub-Investigator:
          • Cory Heal, MD
        • Sub-Investigator:
          • John Davis, MD
        • Principal Investigator:
          • Brenda Moorthy, DO
        • Sub-Investigator:
          • Apar Gupta, MD
        • Sub-Investigator:
          • Elizabeth Jeans, MD
        • Sub-Investigator:
          • Rezwan Chowdhury, MD
        • Sub-Investigator:
          • Christi Bourne, MD
        • Sub-Investigator:
          • Gerald Lucas, MD
        • Sub-Investigator:
          • Subhakar Mutyala, MD
        • Sub-Investigator:
          • Ashley Dipasquale, MD
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • University of California San Diego
        • Sub-Investigator:
          • James Urbanic, MD
        • Contact:
        • Sub-Investigator:
          • Karen Tye, MD
        • Sub-Investigator:
          • Cathryn Yashar, MD
        • Sub-Investigator:
          • Chika Nwachukwu, MD PhD
        • Principal Investigator:
          • Dominique Rash, MD
        • Sub-Investigator:
          • Sara Grossi, MD
        • Sub-Investigator:
          • Gina Masny, MD
        • Sub-Investigator:
          • Ava Armani, MD
        • Sub-Investigator:
          • Anne Wallace, MD
        • Sub-Investigator:
          • Asona Lui, MD PhD
        • Sub-Investigator:
          • Jyoti Mayadev, MD
        • Principal Investigator:
          • Sarah Blair, MD
        • Sub-Investigator:
          • Julie Le, MD
      • San Mateo, California, United States, 94401
        • Recruiting
        • Sutter Health
        • Sub-Investigator:
          • Chris Neville, MD
        • Sub-Investigator:
          • Janice Ryu, MD
        • Sub-Investigator:
          • Nitin Rohatgi, MD
        • Contact:
        • Sub-Investigator:
          • Daniel Schiffner, MD
        • Sub-Investigator:
          • Al Taira, MD
        • Principal Investigator:
          • Dhara MacDermed, MD
        • Principal Investigator:
          • Amanda Wheeler, MD
        • Sub-Investigator:
          • Anne Peled, MD
        • Sub-Investigator:
          • Roy Abendroth, MD
        • Sub-Investigator:
          • Sharon Dutton, MD
        • Sub-Investigator:
          • Patricia Seid, MD
        • Sub-Investigator:
          • Charlotte Kubicky, MD
        • Sub-Investigator:
          • Michael Zhang, MD
        • Sub-Investigator:
          • Natalia Colocci, MD
        • Sub-Investigator:
          • Jorge Garcia-Young, MD
        • Sub-Investigator:
          • Vikram Jairam, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Principal Investigator:
          • Rachel Rabinovitch, MD
        • Principal Investigator:
          • Sarah Tevis, MD
        • Sub-Investigator:
          • Nicole Christian, MD
        • Contact:
        • Sub-Investigator:
          • Christine Fisher, MD MPH
        • Sub-Investigator:
          • Blair Murphy, MD
        • Sub-Investigator:
          • Tim Waxweiler, MD
        • Sub-Investigator:
          • Rebekah Maymani, MD
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Sub-Investigator:
          • Julie Greenwalt, MD
        • Principal Investigator:
          • Laila Samiian, MD
        • Principal Investigator:
          • Cynthia Anderson, MD
        • Sub-Investigator:
          • Karen Ching-Tismal, MD
        • Sub-Investigator:
          • Cathryn Johnson, MD
        • Sub-Investigator:
          • Mona Janfaza, MD
        • Contact:
        • Sub-Investigator:
          • Mark Augspurger, MD
        • Sub-Investigator:
          • Lillie Osteen, MD
        • Sub-Investigator:
          • Neenad Shah, MD
      • Tampa, Florida, United States, 33613
        • Recruiting
        • University of South Florida
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abigail Beard, MD
        • Sub-Investigator:
          • Sarah Merkel, MD
      • Tampa, Florida, United States, 33607
        • Recruiting
        • BayCare Health System
        • Principal Investigator:
          • Robert Gabordi, MD
        • Contact:
        • Sub-Investigator:
          • Negar Golesorkhi, MD
        • Principal Investigator:
          • Nitesh Paryani, MD
        • Sub-Investigator:
          • Geraldine Jacobson, MD
        • Sub-Investigator:
          • Ronica Nanda, MD
        • Sub-Investigator:
          • Roberto Diaz, MD
        • Sub-Investigator:
          • Paula Lundgren, MD
        • Sub-Investigator:
          • Bansi Savla, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Winship Cancer Institute
        • Sub-Investigator:
          • Ashish Patel, MD
        • Sub-Investigator:
          • Clara Farley, MD
        • Contact:
        • Sub-Investigator:
          • Sandra Parker, NP-C
        • Sub-Investigator:
          • Paige Estep, NP
        • Sub-Investigator:
          • Heather Gatcombe, MD
        • Sub-Investigator:
          • Kristin Ward, MD
        • Sub-Investigator:
          • Reshma Jagsi, MD DPhil
        • Sub-Investigator:
          • Rohini Bhatia, MD
        • Sub-Investigator:
          • Toncred Styblo, MD
        • Sub-Investigator:
          • Cletus Arciero, MD
        • Principal Investigator:
          • Monica Rizzo, MD
        • Sub-Investigator:
          • Suniah Ayub, MD
        • Sub-Investigator:
          • Vishal Dhere, MD
        • Sub-Investigator:
          • Sunil Dutta, MD
        • Sub-Investigator:
          • Mylin Torres, MD
        • Sub-Investigator:
          • Natalie Ridge, DO
        • Sub-Investigator:
          • Jolinta Lin, MD
        • Sub-Investigator:
          • Karen Godette, MD
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Endeavor Health (Northshore)
        • Contact:
        • Sub-Investigator:
          • Katherine Kopkash, MD
        • Sub-Investigator:
          • Elizabeth Poli, MD
        • Sub-Investigator:
          • Gary Schreiber, MD
        • Sub-Investigator:
          • Thomas TJ Smith, MD
        • Principal Investigator:
          • Katharine Yao, MD
        • Sub-Investigator:
          • Cecylia Mizera, MD
        • Principal Investigator:
          • Vathsala Raghavan, MD
        • Sub-Investigator:
          • Catherine Pesce, MD
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • Medstar Health Research Institute
        • Sub-Investigator:
          • Paul Fowler, MD
        • Sub-Investigator:
          • Atsuko Okabe, MD
        • Sub-Investigator:
          • Kelly Orwat, MD
        • Contact:
        • Sub-Investigator:
          • Jennifer Son, MD
        • Sub-Investigator:
          • Luther Ampey, MD
        • Sub-Investigator:
          • Maen Farha, MD
        • Principal Investigator:
          • Patricia Wehner, MD
        • Sub-Investigator:
          • Andrew Satinsky, MD
        • Sub-Investigator:
          • Marc Boisvert, MD
        • Sub-Investigator:
          • Daria Abolghasemi, DO
        • Sub-Investigator:
          • Pamela Randolph-Jackson, MD
        • Sub-Investigator:
          • Adedamola Omogbehin, MD
        • Principal Investigator:
          • Katherine Chen, MD
        • Sub-Investigator:
          • Stephen Ronson, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Dana-Farber Cancer Institute
        • Sub-Investigator:
          • Thanh Barbie, MD
        • Sub-Investigator:
          • Laura Dominici, MD
        • Sub-Investigator:
          • Faina Nakhlis, MD
        • Sub-Investigator:
          • Esther Rhei, MD
        • Sub-Investigator:
          • Julia Wong, MD
        • Sub-Investigator:
          • Rinaa Punglia, MD
        • Sub-Investigator:
          • Laura Warren, MD
        • Sub-Investigator:
          • Suniti Nimbkar, MD
        • Sub-Investigator:
          • Olga Kantor, MD
        • Sub-Investigator:
          • Christina Minami, MD
        • Principal Investigator:
          • Jennifer Bellon, MD
        • Contact:
        • Sub-Investigator:
          • Alexis Graham-Stephenson, MD
        • Sub-Investigator:
          • Christopher Vetter, MD
        • Sub-Investigator:
          • Ron Shiloh, MD
        • Sub-Investigator:
          • Brigid Killelea, MD
        • Sub-Investigator:
          • Jennifer Pretz, MD
        • Principal Investigator:
          • Elizabeth Mittendorf, MD PhD
        • Sub-Investigator:
          • Fallon Chipidza, MD
        • Sub-Investigator:
          • Ko Park, MD
        • Sub-Investigator:
          • Stephanie MacAusland, MD
        • Sub-Investigator:
          • Yilin Cao, MD
        • Sub-Investigator:
          • Daphna Spiegel, MD
        • Sub-Investigator:
          • Graham Boyd, MD
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Corewell Health William Beaumont University Center
        • Principal Investigator:
          • Nayana Dekhne, MD
        • Sub-Investigator:
          • Sayee Kiran, MD
        • Contact:
        • Sub-Investigator:
          • Joshua Dilworth, MD PhD
        • Sub-Investigator:
          • Sirisha Nandalur, MD
        • Sub-Investigator:
          • Zakiya Shakir, MD
      • Troy, Michigan, United States, 48098
        • Recruiting
        • Comprehensive Breast Care
        • Sub-Investigator:
          • Linsey Gold, DO
        • Sub-Investigator:
          • Ashley Richardson, DO
        • Contact:
        • Principal Investigator:
          • Rick Brown, MD
        • Principal Investigator:
          • Frank Vicini, MD
        • Sub-Investigator:
          • Vito Antonucci, MD
        • Sub-Investigator:
          • Anita Antoniolli, MD
        • Sub-Investigator:
          • Elizabeth Ekkel-Ayoub, DO
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Sub-Investigator:
          • William Gillanders, MD
        • Contact:
        • Sub-Investigator:
          • Rebecca Aft, MD PhD
        • Principal Investigator:
          • Julie Margenthaler, MD
        • Principal Investigator:
          • Imran Zoberi, MD
        • Sub-Investigator:
          • Katherine Glover-Collins, MD PhD
        • Sub-Investigator:
          • Maria Thomas, MD PhD
        • Sub-Investigator:
          • Carmen Bergom, MD PhD
    • New York
      • Brooklyn, New York, United States, 11220
        • Recruiting
        • Maimonides Cancer Center
        • Sub-Investigator:
          • Charusheela Andaz, MD
        • Sub-Investigator:
          • David Berlach, MD
        • Contact:
        • Sub-Investigator:
          • Joshua Feinberg, MD
        • Sub-Investigator:
          • Jonathan Klein, MD
        • Principal Investigator:
          • Patrick Borgen, MD
        • Sub-Investigator:
          • Catherine Chappuis, MD
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health Center for Advanced Medicine
        • Sub-Investigator:
          • Beatrice Bloom, MD
        • Sub-Investigator:
          • Heather Zinkin, MD
        • Sub-Investigator:
          • Janna Andrews, MD
        • Sub-Investigator:
          • Ashwatha Narayana, MD
        • Contact:
        • Principal Investigator:
          • Brianna Jones, MD
        • Sub-Investigator:
          • Wesley Talcott, MD
        • Principal Investigator:
          • Paul Baron, MD
        • Sub-Investigator:
          • Lucille Lee, MD
        • Sub-Investigator:
          • Ranjana Chaterji, DO
        • Sub-Investigator:
          • Leila Tchelebi, MD
        • Sub-Investigator:
          • Clary Evans, MD
        • Sub-Investigator:
          • Pond Kelemen, MD
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU - Long Island
        • Contact:
        • Sub-Investigator:
          • Jonathan Haas, MD
        • Principal Investigator:
          • Zhanna Logman, MD
        • Sub-Investigator:
          • Amy Solan, MD
        • Sub-Investigator:
          • Helen Pass, MD
        • Sub-Investigator:
          • Sooojin Ahn, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
        • Sub-Investigator:
          • Zahra Ghiassi-Nejad, MD PhD
        • Sub-Investigator:
          • Julie Choi, MD
        • Principal Investigator:
          • Arith Reyes, MD
        • Principal Investigator:
          • Eileen Connolly, MD PhD
        • Sub-Investigator:
          • Bret Taback, MD
        • Sub-Investigator:
          • Leah Katz, MD
        • Sub-Investigator:
          • Roshni Rao, MD
        • Sub-Investigator:
          • Lisa Wiechmann, MD
        • Sub-Investigator:
          • Kristine Kim, MD
        • Sub-Investigator:
          • Luona Sun, MD
        • Sub-Investigator:
          • Lawrence Koutcher, MD
        • Sub-Investigator:
          • Albert Lee, MD
      • New York, New York, United States, 10016
        • Recruiting
        • NYU - Manhattan
        • Principal Investigator:
          • Naamit Gerber, MD
        • Principal Investigator:
          • Freya Schnabel, MD
        • Contact:
        • Sub-Investigator:
          • Mary Gemignani, MD
        • Sub-Investigator:
          • Deborah Axelrod, MD
        • Sub-Investigator:
          • Olivier Maisonet, NP
        • Sub-Investigator:
          • Camille Hardy-Abeloos, MD
        • Sub-Investigator:
          • Oren Cahlon, MD
        • Sub-Investigator:
          • Yuliya Sundatova, NP
        • Sub-Investigator:
          • Amber Guth, MD
    • Ohio
      • Akron, Ohio, United States, 44302
        • Recruiting
        • Cleveland Clinic Akron General
        • Principal Investigator:
          • Susan Hong, MD
        • Contact:
        • Sub-Investigator:
          • Amanda Mendiola, MD
        • Sub-Investigator:
          • Mary Murray, MD
        • Principal Investigator:
          • Andrew Fenton, MD
        • Sub-Investigator:
          • Ashok Ramalingam, MD
        • Sub-Investigator:
          • Praveen Pendyala, MD
        • Sub-Investigator:
          • Salem Alfaifi, MD
        • Sub-Investigator:
          • Sarah Grabowski, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation-Taussig Cancer Inst
        • Sub-Investigator:
          • Susan Hong, MD
        • Sub-Investigator:
          • Ashok Ramalingam, MD
        • Sub-Investigator:
          • Sarah Grabowski, MD
        • Contact:
        • Sub-Investigator:
          • Anna Chichura, MD
        • Sub-Investigator:
          • Andrew Vassil, MD
        • Sub-Investigator:
          • Henry Blair, MD
        • Sub-Investigator:
          • Debra Pratt, MD
        • Sub-Investigator:
          • Julie Lang, MD
        • Sub-Investigator:
          • Anthony Mastroianni, MD JD
        • Principal Investigator:
          • Praveen Pendyala, MD
        • Sub-Investigator:
          • Betty Obi, MD
        • Sub-Investigator:
          • Vincent Wu, MD
        • Sub-Investigator:
          • Paula Escobar, MD
        • Sub-Investigator:
          • Lauren Kopicky, DO
        • Sub-Investigator:
          • Stephanie Valente, DO
        • Sub-Investigator:
          • Joycelin Canavan, MD
        • Sub-Investigator:
          • Michael Weller, MD
        • Sub-Investigator:
          • Zahraa AlHilli, MD
      • Columbus, Ohio, United States, 43212
        • Recruiting
        • The Ohio State University
        • Contact:
        • Sub-Investigator:
          • William Carson, MD
        • Principal Investigator:
          • Doreen Agnese, MD
        • Sub-Investigator:
          • Samilia Obeng-Gyasi, MD MPH
        • Sub-Investigator:
          • Therese Andraos, MD
        • Sub-Investigator:
          • Sachin Jhawar, MD
        • Sub-Investigator:
          • Jacob Eckstein, MD
        • Sub-Investigator:
          • Rebekah Young, MD
        • Sub-Investigator:
          • Valerie Grignol, MD
        • Sub-Investigator:
          • Sasha Beyer, MD PhD
    • Oregon
      • Tigard, Oregon, United States, 97223
        • Recruiting
        • Compass Oncology
        • Contact:
        • Sub-Investigator:
          • Kiri Cook, MD
        • Sub-Investigator:
          • Scott Schneider, MD
        • Sub-Investigator:
          • John Schuler, MD
        • Principal Investigator:
          • Tris Arscott, MD
        • Sub-Investigator:
          • Kati Dunham, MD
        • Principal Investigator:
          • Tammy De La Melena, MD
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • Recruiting
        • St Luke's University Health Network
        • Sub-Investigator:
          • William Smith, MD
        • Contact:
        • Sub-Investigator:
          • Ahmad Rahman, MD
        • Sub-Investigator:
          • Nicholas Cardiges, MD
        • Sub-Investigator:
          • Bhartesh Shah, MD
        • Sub-Investigator:
          • Benjamin Foster, MD
        • Sub-Investigator:
          • Cassandra Cardarelli, MD
        • Sub-Investigator:
          • David Andolino, MD
        • Sub-Investigator:
          • Grace Fan, MD
        • Principal Investigator:
          • Tricia Kelly, MD
        • Principal Investigator:
          • Eleanor Harris, MD
      • Philadelphia, Pennsylvania, United States, 19027
        • Recruiting
        • Sidney Kimmel Comprehensive Cancer Ctr - Jefferson
        • Principal Investigator:
          • Scott Herbert, MD
        • Contact:
        • Principal Investigator:
          • Stefania Nolano, DO
        • Sub-Investigator:
          • Nicole Simone, MD
        • Sub-Investigator:
          • Kristin Brill, MD
        • Sub-Investigator:
          • Seye Adekeye, MD PhD
        • Sub-Investigator:
          • Susanna Nazarian, MD PhD
        • Sub-Investigator:
          • Pramila Anne, MD
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • AHN Allegheny General Hospital
        • Contact:
        • Sub-Investigator:
          • Ryan VanDenBerg, MD
        • Sub-Investigator:
          • Gunj Patel, MD
        • Sub-Investigator:
          • Jennifer Saldanha, MD
        • Sub-Investigator:
          • Talal Khan, MD
        • Sub-Investigator:
          • Adam Johnson, MD
        • Sub-Investigator:
          • Rubal Sharma, MD
        • Sub-Investigator:
          • Mark Gannon, MD
        • Principal Investigator:
          • Bindu Rusia, MD
        • Sub-Investigator:
          • Paul Renz, DO
        • Sub-Investigator:
          • Basem Dahshan, MD
        • Sub-Investigator:
          • Athanasios Colonias, MD
        • Sub-Investigator:
          • Saleha Rizwan, MD
        • Sub-Investigator:
          • Conrad Stachelek, MD PhD
        • Sub-Investigator:
          • James Betler, DO
        • Sub-Investigator:
          • Emil Fernando, MD
        • Sub-Investigator:
          • Mary Freyvogel-Ramirez, MD
        • Sub-Investigator:
          • Colin Champ, MD
        • Sub-Investigator:
          • Amanda Deliere, MD
        • Principal Investigator:
          • Suzanna Coopey, MD
        • Sub-Investigator:
          • Pritam Tayshetye, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Nashville Breast Center
        • Contact:
        • Principal Investigator:
          • Eduardo Dias, MD
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • UT Southwestern Medical Center
        • Contact:
        • Principal Investigator:
          • Mona Arbab, MD
        • Sub-Investigator:
          • Rachel Wooldridge, MD
        • Sub-Investigator:
          • Anvy Nguyen, MD
        • Sub-Investigator:
          • Dillon Li, MD
        • Sub-Investigator:
          • Stephanie Serres, MD PhD
        • Principal Investigator:
          • Deborah Farr, MD
        • Sub-Investigator:
          • Maureen Aliru, MD PhD
        • Sub-Investigator:
          • Anthony Froix, MD
        • Sub-Investigator:
          • Asal Rahimi, MD
        • Sub-Investigator:
          • Narine Wandrey, MD
        • Sub-Investigator:
          • Prasanna Alluri, MD PhD
        • Sub-Investigator:
          • Shruti Zaveri, MD
        • Sub-Investigator:
          • Marilyn Leitch, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Principal Investigator:
          • Elizabeth Bonefas, MD
        • Sub-Investigator:
          • Alastair Thompson, MD
        • Sub-Investigator:
          • Stacey Carter, MD
        • Sub-Investigator:
          • Eric Silberfein, MD
        • Sub-Investigator:
          • Cary Hsu, MD
        • Contact:
        • Principal Investigator:
          • Shelly Sharma, MD
        • Sub-Investigator:
          • Snehal Desai, MD
        • Sub-Investigator:
          • Daniel Hamstra, MD PhD
        • Sub-Investigator:
          • Christina Chapman, MD
        • Sub-Investigator:
          • Krystal Morales Rivera, MD PhD
      • Plano, Texas, United States, 75093
        • Recruiting
        • Texas Oncology
        • Contact:
        • Principal Investigator:
          • Lynn Canavan, MD
        • Principal Investigator:
          • James Petrikas, DO

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

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be selected from the clinical practices of the participating investigators and institutions. Patients who have been recently diagnosed with DCIS and are being evaluated for the need for further therapy will be screened for eligibility per the following eligibility criteria. Female patients 30 to 85 years with histologically confirmed ductal carcinoma in situ (DCIS) in a single breast of size less than 6 cm without evidence of invasive or microinvasive cancer and clinically eligible to receive breast-conserving surgery with or without radiation therapy.

Description

Inclusion criteria

  1. Patient must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable).
  2. Patient must have the DCISionRT test ordered during routine patient care.
  3. Patient must be eligible for or have recently completed breast conserving surgery.
  4. Patient must be eligible to receive radiation and/or systemic treatment.
  5. Patient must be 30 to 85 years old.
  6. Patient must have tumor size of less than 6 cm.
  7. Patient must have been diagnosed with DCIS within 120 days of consent.

Exclusion criteria

  1. Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing.
  2. Patient has evidence of invasive breast cancer, including microinvasion, lymph node involvement, or Paget's disease of the nipple or suspicious mammogram findings in the lymph nodes or contralateral breast.
  3. Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.
  4. Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.
  5. Patient has a prior history of in-field radiation in the ipsilateral breast.
  6. Patient has had prior systemic endocrine or chemotherapy prior to testing.
  7. Patient is pregnant.

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: Cohort
  • 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.
DCIS
Patients must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast without evidence of invasive cancer (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable)
Other: Treatment recommendation surveys
Treatment Recommendation Surveys are completed by the treating physicians before and after receiving results from the DCISionRT test, which is prognostic for risk of recurrence over 10 years and predictive for benefit from radiation therapy.
Device: 7-gene biosignature
Ordering the 7-gene biosignature assay (DCISionRT) as a part of routine care for DCIS is a prerequisite (inclusion criterion) for the study. The study is not designed to determine the efficacy of the assay, rather it is designed to meausre the impact of the assay results on treatment decisions for patients with DCIS.

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
Percent of Cases with Changes in Treatment Recommendation
Time Frame: From enrollment to the beginning of treatment.
The percent of cases in which treatment recommendations are changed after the test DCISionRT test results become available. The study will collect details on physician treatment recommendations and patient preference before and after the availability of the molecular test (DCISionRT) results. The data elements include type of surgery (lumpectomy, therapeutic mastectomy, contralateral prophylactic mastectomy), type of radiation therapy (none, IORT, APBI/PBI, whole breast RT, boost) and endocrine therapy.
From enrollment to the beginning of treatment.

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
Function of Tumor Factors
Time Frame: 5 years
Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of tumor factors (tumor size, grade, architecture, necrosis, palpability, surgical margins, hormone receptor status).
5 years
Function of Tumor and Demographic Factors
Time Frame: From enrollment to the beginning of treatment.

Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of tumor factors (tumor size, nuclear grade, architecture, necrosis, palpability, surgical margins, hormone receptor status).

Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of demographic factors (age; ethnicity; family history, education, marital status, geographic region).
From enrollment to the beginning of treatment.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Distribution of DCISionRT scores across the cohort
Time Frame: From enrollment to the beginning of treatment.
Each patient will receive the following results from the DCISionRT test: Decision Score (DS, 0.8-10.0), Residual Risk subtype (DS 9.2).
From enrollment to the beginning of treatment.
Function of Geographic Region
Time Frame: From enrollment to the beginning of treatment.
Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of the geographic region of the investigator, type of institution, or type of treating physician.
From enrollment to the beginning of treatment.

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.
PreludeDx

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of South Florida

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.
  • Principal Investigator: Troy Bremer, PhD, PreludeDx
  • Study Chair: Pat W Whitworth, MD, PreludeDx
  • Study Chair: Rachel Rabinovitch, MD, University of Colorado, Denver
  • Study Chair: Pat Borgen, MD, Maimonides Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
February 27, 2018

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.
December 1, 2026

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, 2036

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 16, 2018

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 27, 2018

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 28, 2018

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.
April 17, 2026

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.
April 14, 2026

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.
April 1, 2026

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.
  • Ext00000206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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