Recruiting

Observational StudyThe PREDICT Registry:

Sponsor:

PreludeDx

Code:

NCT03448926

Conditions

DCIS

Stage 0 Breast Cancer

Ductal Breast Carcinoma In Situ

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Treatment recommendation surveys

7-gene biosignature

Study Details

Brief summary:

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.

Conditions

DCIS

Stage 0 Breast Cancer

Ductal Breast Carcinoma In Situ

Study ID

NCT03448926

Start date

Feb 27, 2018

Status verified date

Apr, 2026

Completion date

Dec, 2036

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Interventions

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.

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.

Primary outcome measure

Percent of Cases with Changes in Treatment Recommendation [ Time Frame: From enrollment to the beginning of treatment. ]

Central Contacts and Locations

Central contacts

Steven C Shivers, PhD

813-215-1749 sshivers@preludedx.com

Leona Hamrick, DHSc

727-244-6411 lhamrick@preludedx.com

Locations

Arizona Center for Cancer Care

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Penny Labriola

480-278-8261 penny.labriola@arizonaccc.com

Shakila Rajack, MBBS

480-278-8300 shakila.rajack@arizonaccc.com

Principal Investigator:

Anushka Patel, MD

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Sauntee Braddock

858-822-6040 sbraddock@health.ucsd.edu

Principal Investigator:

Dominique Rash, MD

Sutter Health

Recruiting

San Mateo, California, United States, 94401

Contacts

Silvia Gonzalez

650-696-4814 silvia.gonzalez3@sutterhealth.org

Principal Investigator:

Dhara MacDermed, MD

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Chitra Pai-Kulyadi

857-919-8557 chitra.paikulyadi@cuanschutz.edu

Principal Investigator:

Sarah Tevis, MD

Baptist MD Anderson Cancer Center

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Austin Anderson

904-202-7501 austin.anderson@bmcjax.com

Principal Investigator:

Laila Samiian, MD

BayCare Health System

Recruiting

Tampa, Florida, United States, 33607

Contacts

Jessica Hupp

813-356-7168 jessica.hupp@baycare.org

Principal Investigator:

Nitesh Paryani, MD

University of South Florida

Recruiting

Tampa, Florida, United States, 33613

Contacts

Gabriela Martinez

305-878-5045 gmartinez4@usf.edu

Renee Veleva

813-821-8034 veleva@usf.edu

Principal Investigator:

Abigail Beard, MD

Emory University Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Carlos Aguilera Zenteno

404-778-4982 carlos.e.aguilera.zenteno@emory.edu

Principal Investigator:

Monica Rizzo, MD

Endeavor Health (Northshore)

Recruiting

Evanston, Illinois, United States, 60201

Contacts

William McMichael

847-570-2393 wmcmichael@northshore.org

Principal Investigator:

Katharine Yao, MD

MedStar Health Research Institute

Recruiting

Baltimore, Maryland, United States, 21237

Contacts

Amy Avergas

443-777-8876 amy.m.avergas@medstar.net

Principal Investigator:

Patricia Wehner, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Amanda Faust

973-818-7077 amanda_faust@dfci.harvard.edu

Principal Investigator:

Jennifer Bellon, MD

Corewell Health William Beaumont University Center

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Lisa Bliss

248-551-5166 lisa.bliss@corewellhealth.org

Principal Investigator:

Nayana Dekhne, MD

Comprehensive Breast Care

Recruiting

Troy, Michigan, United States, 48098

Contacts

Sevasti Vergis, DO

224-636-0898 sevasti.vergis@corewellhealth.org

Principal Investigator:

Rick Brown, MD

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Mary Pecoraro, RN BSN

314-273-0884 mpecoraro@wustl.edu

Principal Investigator:

Julie Margenthaler, MD

Maimonides Cancer Center

Recruiting

Brooklyn, New York, United States, 11220

Contacts

Vijaya Natarajan

718-765-2611 vnatarajan@maimo.org

Principal Investigator:

Patrick Borgen, MD

Northwell Health Center for Advanced Medicine

Recruiting

Lake Success, New York, United States, 11042

Contacts

Olivia Casareno

516-321-2200 ocasareno@northwell.edu

Principal Investigator:

Brianna Jones, MD

NYU - Long Island

Recruiting

Mineola, New York, United States, 11501

Contacts

Nadia Chowdhury

347-327-4988 nadia.chowdhury@nyulangone.org

Principal Investigator:

Zhanna Logman, MD

NYU - Manhattan

Recruiting

New York, New York, United States, 10016

Contacts

Nadia Chowdhury

347-327-4988 nadia.chowdhury@nyulangone.org

Principal Investigator:

Freya Schnabel, MD

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Christina Chesnakov

646-317-4244 cc4047@cumc.columbia.edu

Principal Investigator:

Arith Reyes, MD

Cleveland Clinic Akron General

Recruiting

Akron, Ohio, United States, 44302

Contacts

Wendy Catchpole

330-344-6348 catchpw@ccf.org

Principal Investigator:

Susan Hong, MD

Cleveland Clinic Foundation-Taussig Cancer Inst

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Laura Luxenberg

216-445-5256 luxenbl@ccf.org

Principal Investigator:

Praveen Pendyala, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Jean Koutou

614-293-5637 jeanmartial.koutouessan@osumc.edu

Principal Investigator:

Doreen Agnese, MD

Compass Oncology

Recruiting

Tigard, Oregon, United States, 97223

Contacts

Aidan Walker

971-708-7600 aidan.walker@compassoncology.com

Principal Investigator:

Tris Arscott, MD

St Luke's University Health Network

Recruiting

Easton, Pennsylvania, United States, 18045

Contacts

Helen McGunngle

484-503-4600 helen.mcgunnigle@sluhn.org

Principal Investigator:

Tricia Kelly, MD

Sidney Kimmel Comprehensive Cancer Ctr - Jefferson

Recruiting

Philadelphia, Pennsylvania, United States, 19027

Contacts

Jennifer Greene

215-600-7258 jennifer.greene2@jefferson.edu

Principal Investigator:

Scott Herbert, MD

AHN Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Sarah Bailey-Hockin

412-359-3826 sarah.bailey-hockin@ahn.org

Principal Investigator:

Bindu Rusia, MD

Nashville Breast Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Kristie Appleton

615-415-1802 kristie@nashvillebreastcenter.com

Principal Investigator:

Eduardo Dias, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75235

Contacts

Sarah Neufeld

214-645-8525 sarah.hardee@utsouthwestern.edu

Principal Investigator:

Mona Arbab, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Ivan Marin

713 798-3432 ivan.marin@bcm.edu

Principal Investigator:

Shelly Sharma, MD

Texas Oncology

Recruiting

Plano, Texas, United States, 75093

Contacts

Leah Plato

469-361-1905 leah.plato@usoncology.com

Principal Investigator:

Lynn Canavan, MD

More Information

Sponsor

PreludeDx

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

DCIS
molecular testing
risk of recurrence
treatment decision
decision impact
predictive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by PreludeDx on 2026-04-17.