The PREDICT Registry:

PreludeDx3,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

DCIS

Interventions

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.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (15)

Arizona Center for Cancer Care

Phoenix, Arizona, United States

RECRUITING

Sutter Institute for Medical Research

Outcomes

Primary Outcomes

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.

Time frame: From enrollment to the beginning of treatment.

Secondary Outcomes

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).

Time frame: 5 years

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).

Time frame: From enrollment to the beginning of treatment.

Central Contacts

Steven C Shivers, PhD

CONTACT

813-215-1749 sshivers@preludedx.com

Leona Hamrick, DHSc

CONTACT

727-244-6411 lhamrick@preludedx.com

Data from ClinicalTrials.gov

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