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The PREDICT Registry:

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 85 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 years
  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "The patient may then be followed for up to 10 years (or until death) with completion of 5- and 10-year follow-up forms."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The PREDICT Registry follows people with ductal carcinoma in situ (DCIS), cancer cells that stay inside the breast's milk ducts. It is for people ages 30 to 85 who have DCIS in one breast and a DCISionRT test ordered as part of their usual care. The study observes care rather than assigning treatments.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue test must confirm DCIS in only one breast. LCIS (abnormal cells in milk-making glands) or other noncancer breast conditions are also allowed.
  • A DCISionRT test must be ordered as part of your usual care.
  • You must be able to have, or have recently had, surgery that removes the cancer but keeps the breast.
  • You must be able to receive radiation, medicine that treats cancer throughout the body, or both.
  • You must be 30 to 85 years old.
  • The tumor must be smaller than 6 centimeters.
  • Your DCIS diagnosis must be within 120 days before you agree to join.

Who can't join

  • There is not enough tissue for the DCISionRT test, or needed details are missing: age, tumor size, whether cancer is at the edge of removed tissue, or whether the tumor can be felt.
  • You have breast cancer that has spread outside the milk ducts, even a tiny amount; cancer in lymph nodes; Paget's disease (cancer of the nipple); or a mammogram showing suspicious findings in lymph nodes or the other breast.
  • You had the breast with DCIS removed to treat this cancer.
  • You have had DCIS or invasive breast cancer in either breast before.
  • You had radiation before in the same area of the breast with DCIS.
  • You had hormone treatment that acts throughout the body or chemotherapy before the test.
  • You are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (30)

AZ

CA

CO

FL

GA

IL

MA

MD

MI

MO

  • Washington University School of Medicine · St Louis, MO 63110Mary Pecoraro, RN BSN · Study contact · 314-273-0884 · mpecoraro@wustl.eduRebecca Aft, MD PhD · Sub-investigatorJulie Margenthaler, MD · Principal investigatorImran Zoberi, MD · Principal investigatorMore trials in St Louis

NY

OH

OR

PA

TN

TX