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New test may help tailor treatment for early breast cancer

NCT ID NCT03448926

Knowledge-focused Sponsor: PreludeDx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is observing how a genetic test called DCISionRT influences treatment decisions for people with ductal carcinoma in situ (DCIS), a very early form of breast cancer. The test predicts the risk of the cancer returning over 10 years and whether radiation therapy would be helpful. Doctors will record their treatment recommendations before and after seeing the test results to see if the test changes their advice. The study involves 3,000 participants and is not testing a new drug or treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could show that using the DCISionRT test helps doctors and patients make more informed, personalized treatment decisions for DCIS, potentially reducing unnecessary treatments.
What could go wrong
This is an observational study, not a treatment trial. It measures changes in recommendations, not patient outcomes. The test's real-world impact on health is not directly assessed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2018

Expected to finish

Dec 2036

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

30 to 85 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast carcinoma in situ ductal breast carcinoma in situ

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DCIS Ductal breast carcinoma in situ Stage 0 breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AHN Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Arizona Center for Cancer Care

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Baptist MD Anderson Cancer Center

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • BayCare Health System

    RECRUITING

    Tampa, Florida, 33607, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Cleveland Clinic Akron General

    RECRUITING

    Akron, Ohio, 44302, United States

  • Cleveland Clinic Foundation-Taussig Cancer Inst

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Compass Oncology

    RECRUITING

    Tigard, Oregon, 97223, United States

  • Comprehensive Breast Care

    RECRUITING

    Troy, Michigan, 48098, United States

  • Corewell Health William Beaumont University Center

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Emory University Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Endeavor Health (Northshore)

    RECRUITING

    Evanston, Illinois, 60201, United States

  • Maimonides Cancer Center

    RECRUITING

    Brooklyn, New York, 11220, United States

  • MedStar Health Research Institute

    RECRUITING

    Baltimore, Maryland, 21237, United States

  • NYU - Long Island

    RECRUITING

    Mineola, New York, 11501, United States

  • NYU - Manhattan

    RECRUITING

    New York, New York, 10016, United States

  • Nashville Breast Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Northwell Health Center for Advanced Medicine

    RECRUITING

    Lake Success, New York, 11042, United States

  • Sidney Kimmel Comprehensive Cancer Ctr - Jefferson

    RECRUITING

    Philadelphia, Pennsylvania, 19027, United States

  • St Luke's University Health Network

    RECRUITING

    Easton, Pennsylvania, 18045, United States

  • Sutter Health

    RECRUITING

    San Mateo, California, 94401, United States

  • Texas Oncology

    RECRUITING

    Plano, Texas, 75093, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43212, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75235, United States

  • University of California San Diego

    RECRUITING

    La Jolla, California, 92093, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33613, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.