The PREDICT Registry:

NCT03448926 | Recruiting FDA Device

• 1 other identifier: Ext00000206
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 30

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

Keywords

DCIS; molecular testing; risk of recurrence; treatment decision; decision impact; predictive

Outcome Measures

Primary Outcomes (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.

  From enrollment to the beginning of treatment.

Secondary Outcomes (2)

• Function of Tumor Factors

  5 years

• Function of Tumor and Demographic Factors

  From enrollment to the beginning of treatment.

Other Outcomes (2)

• Distribution of DCISionRT scores across the cohort

  From enrollment to the beginning of treatment.

• Function of Geographic Region

  From enrollment to the beginning of treatment.

Study Arms (1)

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; Device: 7-gene biosignature

Interventions

Treatment recommendation surveys OTHER

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.

DCIS

7-gene biosignature DEVICE

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.

DCIS

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PreludeDx: lead

Study Sites (30)

Arizona Center for Cancer Care

Scottsdale, Arizona, 85258, United States

RECRUITING

University of California San Diego

La Jolla, California, 92093, United States

RECRUITING

Sutter Health

San Mateo, California, 94401, United States

RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

RECRUITING

BayCare Health System

Tampa, Florida, 33607, United States

RECRUITING

University of South Florida

Tampa, Florida, 33613, United States

RECRUITING

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Endeavor Health (Northshore)

Evanston, Illinois, 60201, United States

RECRUITING

MedStar Health Research Institute

Baltimore, Maryland, 21237, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Corewell Health William Beaumont University Center

Royal Oak, Michigan, 48073, United States

RECRUITING

Comprehensive Breast Care

Troy, Michigan, 48098, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Maimonides Cancer Center

Brooklyn, New York, 11220, United States

RECRUITING

Northwell Health Center for Advanced Medicine

Lake Success, New York, 11042, United States

RECRUITING

NYU - Long Island

Mineola, New York, 11501, United States

RECRUITING

NYU - Manhattan

New York, New York, 10016, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Cleveland Clinic Akron General

Akron, Ohio, 44302, United States

RECRUITING

Cleveland Clinic Foundation-Taussig Cancer Inst

Cleveland, Ohio, 44195, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43212, United States

RECRUITING

Compass Oncology

Tigard, Oregon, 97223, United States

RECRUITING

St Luke's University Health Network

Easton, Pennsylvania, 18045, United States

RECRUITING

Sidney Kimmel Comprehensive Cancer Ctr - Jefferson

Philadelphia, Pennsylvania, 19027, United States

RECRUITING

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Nashville Breast Center

Nashville, Tennessee, 37203, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Texas Oncology

Plano, Texas, 75093, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 40685017 BACKGROUND

• 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.

  PMID: 34885211 BACKGROUND

• 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.

  PMID: 36115740 BACKGROUND

• 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.

  PMID: 37274253 BACKGROUND

• 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.

  PMID: 33997922 RESULT

• 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.

  PMID: 38916700 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Primary tumor blocks

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Troy Bremer, PhD

  PreludeDx

  PRINCIPAL INVESTIGATOR

• Pat W Whitworth, MD

  PreludeDx

  STUDY CHAIR

• Rachel Rabinovitch, MD

  University of Colorado, Denver

  STUDY CHAIR

• Pat Borgen, MD

  Maimonides Medical Center

  STUDY CHAIR

Central Study Contacts

Steven C Shivers, PhD

CONTACT

813-215-1749; sshivers@preludedx.com

Leona Hamrick, DHSc

CONTACT

727-244-6411; lhamrick@preludedx.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 28, 2018
• Study Start: February 27, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2036
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (30)