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DCISNCT03448926

The PREDICT Registry:

An observational study of DCIS and Stage 0 Breast Cancer, run by PreludeDx at 30 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 85 years, women only
What is being tested?
Treatment recommendation surveys and 7-gene biosignature
Type of treatment
Medical device
How many people
3,000 participants
Where
30 sitesUnited States
Study dates
27 Feb 2018to Dec 2036
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).
  • Patient must have the DCISionRT test ordered during routine patient care.
  • Patient must be eligible for or have recently completed breast conserving surgery.
  • Patient must be eligible to receive radiation and/or systemic treatment.
  • Patient must be 30 to 85 years old.
  • Patient must have tumor size of less than 6 cm.
  • Patient must have been diagnosed with DCIS within 120 days of consent.

Who cannot join

  • Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing.
  • 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.
  • Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.
  • Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.
  • Patient has a prior history of in-field radiation in the ipsilateral breast.
  • Patient has had prior systemic endocrine or chemotherapy prior to testing.
  • Patient is pregnant.

Trial locations and contacts

30 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Steven C Shivers, PhD contact

813-215-1749

sshivers@preludedx.com

Leona Hamrick, DHSc contact

727-244-6411

lhamrick@preludedx.com

30 sites in 1 country

United States30 sites, 30 recruiting

  • Cleveland Clinic Akron General

    Akron, Ohio, 44302

    Wendy Catchpole, 330-344-6348, catchpw@ccf.org

    Amanda Mendiola, MD

    Recruiting

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

    Carlos Aguilera Zenteno, 404-778-4982, carlos.e.aguilera.zenteno@emory.edu

    Sandra Parker, NP-C

    Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

    Chitra Pai-Kulyadi, 857-919-8557, chitra.paikulyadi@cuanschutz.edu

    Nicole Christian, MD

    Recruiting

  • MedStar Health Research Institute

    Baltimore, Maryland, 21237

    Amy Avergas, 443-777-8876, amy.m.avergas@medstar.net

    Jennifer Son, MD

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

    Amanda Faust, 973-818-7077, amanda_faust@dfci.harvard.edu

    Faina Nakhlis, MD

    Recruiting

  • Maimonides Cancer Center

    Brooklyn, New York, 11220

    Vijaya Natarajan, 718-765-2611, vnatarajan@maimo.org

    Joshua Feinberg, MD

    Recruiting

  • Cleveland Clinic Foundation-Taussig Cancer Inst

    Cleveland, Ohio, 44195

    Laura Luxenberg, 216-445-5256, luxenbl@ccf.org

    Anna Chichura, MD

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43212

    Jean Koutou, 614-293-5637, jeanmartial.koutouessan@osumc.edu

    William Carson, MD

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

    Sarah Neufeld, 214-645-8525, sarah.hardee@utsouthwestern.edu

    Rachel Wooldridge, MD

    Recruiting

  • St Luke's University Health Network

    Easton, Pennsylvania, 18045

    Helen McGunngle, 484-503-4600, helen.mcgunnigle@sluhn.org

    Ahmad Rahman, MD

    Recruiting

  • Endeavor Health (Northshore)

    Evanston, Illinois, 60201

    William McMichael, 847-570-2393, wmcmichael@northshore.org

    Katherine Kopkash, MD

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Ivan Marin, 713 798-3432, ivan.marin@bcm.edu

    Shelly Sharma, MD

    Recruiting

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

    Austin Anderson, 904-202-7501, austin.anderson@bmcjax.com

    Julie Greenwalt, MD

    Recruiting

  • University of California San Diego

    La Jolla, California, 92093

    Sauntee Braddock, 858-822-6040, sbraddock@health.ucsd.edu

    Karen Tye, MD

    Recruiting

  • Northwell Health Center for Advanced Medicine

    Lake Success, New York, 11042

    Olivia Casareno, 516-321-2200, ocasareno@northwell.edu

    Brianna Jones, MD

    Recruiting

  • NYU - Long Island

    Mineola, New York, 11501

    Nadia Chowdhury, 347-327-4988, nadia.chowdhury@nyulangone.org

    Jonathan Haas, MD

    Recruiting

  • Nashville Breast Center

    Nashville, Tennessee, 37203

    Kristie Appleton, 615-415-1802, kristie@nashvillebreastcenter.com

    Eduardo Dias, MD

    Recruiting

  • NYU - Manhattan

    New York, New York, 10016

    Nadia Chowdhury, 347-327-4988, nadia.chowdhury@nyulangone.org

    Freya Schnabel, MD

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Christina Chesnakov, 646-317-4244, cc4047@cumc.columbia.edu

    Zahra Ghiassi-Nejad, MD PhD

    Recruiting

  • Sidney Kimmel Comprehensive Cancer Ctr - Jefferson

    Philadelphia, Pennsylvania, 19027

    Jennifer Greene, 215-600-7258, jennifer.greene2@jefferson.edu

    Scott Herbert, MD

    Recruiting

  • AHN Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Sarah Bailey-Hockin, 412-359-3826, sarah.bailey-hockin@ahn.org

    Ryan VanDenBerg, MD

    Recruiting

  • Texas Oncology

    Plano, Texas, 75093

    Leah Plato, 469-361-1905, leah.plato@usoncology.com

    Lynn Canavan, MD

    Recruiting

  • Corewell Health William Beaumont University Center

    Royal Oak, Michigan, 48073

    Lisa Bliss, 248-551-5166, lisa.bliss@corewellhealth.org

    Sayee Kiran, MD

    Recruiting

  • Sutter Health

    San Mateo, California, 94401

    Silvia Gonzalez, 650-696-4814, silvia.gonzalez3@sutterhealth.org

    Daniel Schiffner, MD

    Recruiting

  • Arizona Center for Cancer Care

    Scottsdale, Arizona, 85258

    Penny Labriola, 480-278-8261, penny.labriola@arizonaccc.com

    Shakila Rajack, MBBS, 480-278-8300, shakila.rajack@arizonaccc.com

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Mary Pecoraro, RN BSN, 314-273-0884, mpecoraro@wustl.edu

    Rebecca Aft, MD PhD

    Recruiting

  • BayCare Health System

    Tampa, Florida, 33607

    Jessica Hupp, 813-356-7168, jessica.hupp@baycare.org

    Negar Golesorkhi, MD

    Recruiting

  • University of South Florida

    Tampa, Florida, 33613

    Gabriela Martinez, 305-878-5045, gmartinez4@usf.edu

    Renee Veleva, 813-821-8034, veleva@usf.edu

    Recruiting

  • Compass Oncology

    Tigard, Oregon, 97223

    Aidan Walker, 971-708-7600, aidan.walker@compassoncology.com

    Kiri Cook, MD

    Recruiting

  • Comprehensive Breast Care

    Troy, Michigan, 48098

    Sevasti Vergis, DO, 224-636-0898, sevasti.vergis@corewellhealth.org

    Rick Brown, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Treatment recommendation surveys, 7-gene biosignature
Keywords
DCIS, molecular testing, risk of recurrence, treatment decision, decision impact, predictive
Medical subject headings
Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment recommendation surveysOther

    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 biosignatureDevice

    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.

Study groups in NCT03448926
Study groupRoleWhat they receive
DCISPatients 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)
Receives: Other: Treatment recommendation surveys; Device: 7-gene biosignature

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of Cases with Changes in Treatment Recommendation

    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.

    Measured: From enrollment to the beginning of treatment.

Secondary outcomes (2)

  1. Function of Tumor Factors

    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).

    Measured: 5 years

  2. Function of Tumor and Demographic Factors

    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).

    Measured: From enrollment to the beginning of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2018
  2. Study start27 Feb 2018
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03448926
Sponsor's protocol ID
Ext00000206
Status last verified
Apr 2026
First submitted
16 Feb 2018
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Vicini F, Shah C, Mittal K, Weinmann S, Leo M, Mann GB, Warnberg F, Rabinovitch R, Czerniecki B, Meattini I, Khan AJ, Jhawar S, Gerber N, Willey SC, Borgen P, AlHilli Z, Kruse M, Dabbs D, Shivers SC, Daily A, Whitworth P, Alvarado M, Mouabbi JA, Moran M, Rugo H, O'Shaughnessy JA, Bremer T. Limitations in the Application of Clinicopathologic Factors Alone in Predicting Radiation Benefit for Women With Low-Risk Ductal Carcinoma In Situ After Breast Conserving Surgery: The Impact of a 7-Gene Biosignature Based on 10-Year Ipsilateral Breast Recurrence Rates. Int J Radiat Oncol Biol Phys. 2025 Nov 15;123(4):1090-1101. doi: 10.1016/j.ijrobp.2025.07.1411. Epub 2025 Jul 18.

    PubMed 40685017

  • Warnberg F, Karlsson P, Holmberg E, Sandelin K, Whitworth PW, Savala J, Barry T, Leesman G, Linke SP, Shivers SC, Vicini F, Shah C, Weinmann S, Mann GB, Bremer T. Prognostic Risk Assessment and Prediction of Radiotherapy Benefit for Women with Ductal Carcinoma In Situ (DCIS) of the Breast, in a Randomized Clinical Trial (SweDCIS). Cancers (Basel). 2021 Dec 3;13(23):6103. doi: 10.3390/cancers13236103.

    PubMed 34885211

  • Vicini FA, Mann GB, Shah C, Weinmann S, Leo MC, Whitworth P, Rabinovitch R, Torres MA, Margenthaler JA, Dabbs D, Savala J, Shivers SC, Mittal K, Warnberg F, Bremer T. A Novel Biosignature Identifies Patients With DCIS With High Risk of Local Recurrence After Breast Conserving Surgery and Radiation Therapy. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):93-102. doi: 10.1016/j.ijrobp.2022.06.072. Epub 2022 Sep 15.

    PubMed 36115740

  • Dabbs D, Mittal K, Heineman S, Whitworth P, Shah C, Savala J, Shivers SC, Bremer T. Analytical validation of the 7-gene biosignature for prediction of recurrence risk and radiation therapy benefit for breast ductal carcinoma in situ. Front Oncol. 2023 May 19;13:1069059. doi: 10.3389/fonc.2023.1069059. eCollection 2023.

    PubMed 37274253

  • Shah C, Bremer T, Cox C, Whitworth P, Patel R, Patel A, Brown E, Gold L, Rock D, Riley L, Kesslering C, Brown S, Gabordi R, Pellicane J, Rabinovich R, Khan S, Templeton S, Majithia L, Willey SC, Warnberg F, Gerber NK, Shivers S, Vicini FA. Correction to: The Clinical Utility of DCISionRT(R) on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery. Ann Surg Oncol. 2021 Dec;28(Suppl 3):878. doi: 10.1245/s10434-021-10138-3. No abstract available.

    PubMed 33997922

  • Shah C, Whitworth P, Vicini FA, Narod S, Gerber N, Jhawar SR, King TA, Mittendorf EA, Willey SC, Rabinovich R, Gold L, Brown E, Patel A, Vargo J, Barry PN, Rock D, Friedman N, Bedi G, Templeton S, Brown S, Gabordi R, Riley L, Lee L, Baron P, Majithia L, Mirabeau-Beale KL, Reid VJ, Hirsch A, Hwang C, Pellicane J, Maganini R, Khan S, MacDermed DM, Small W, Mittal K, Borgen P, Cox C, Shivers SC, Bremer T. The Clinical Utility of a 7-Gene Biosignature on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery: An Updated Analysis of the DCISionRT(R) PREDICT Study. Ann Surg Oncol. 2024 Sep;31(9):5919-5928. doi: 10.1245/s10434-024-15566-5. Epub 2024 Jun 25.

    PubMed 38916700

Questions about this trial

What is this clinical trial studying?

An observational study of DCIS and Stage 0 Breast Cancer, run by PreludeDx at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Steven C Shivers, PhD (813-215-1749, sshivers@preludedx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Cases with Changes in Treatment Recommendation (time frame: From enrollment to the beginning of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03448926, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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