The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing

This is a prospective cohort study conducted within the medical network of the

participating investigators and institutions. Patients meeting the eligibility criteria

outlined above will be eligible for participation and the investigators will obtain

written informed consent. A central Institutional Review Board (IRB) will approve the

protocol and each participating institution.

After diagnosis of DCIS, the most representative tissue block (or 10 sections mounted on

charged slides cut at 3 microns) will be sent to PreludeDx for DCISionRT. The most

representative specimen should be selected from tissue collected via direct tumor biopsy

(either FNA, 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).

All study data will be stored in an encrypted, HIPAA-compliant database maintained by the

sponsor. Each consented patient will be assigned a unique Study ID number. Study

personnel at each institution will maintain a 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 anticipates the participation of up to 150 sites within Australia with each

site enrolling between 10 and 100 patients. The study is designed to collect information

for up to 1,500 patients.

The purpose of this study is to create a de-identified database of patients, test

results, treatment decisions and outcomes that can be queried to determine the clinical

utility of the DCISionRT™ Test in the management of DCIS, as it is broadly incorporated

into clinical practice. The primary objective is to identify a statistically significant

difference in physician treatment recommendations for patients diagnosed with DCIS and

treated with breast conserving surgery based on availability of the DCISionRT test

results. The primary endpoints are treatment recommendations according to standard

procedure at each clinical site both pre- and post-DCISionRT results.

Secondary endpoints include the percent of patients for which the recommended treatment

before DCISionRT results and after DCISionRT results differ as a function of clinical

factors, such as age groups (<40, 40-50 and >50), grade (I, II, III), and tumor size

(>1cm, >2.5cm, >4cm). Other analyses involve the identification of key driver(s) of

treatment recommendation, such as age, ethnicity, race, family history, presentation

(screening/clinical), grade, architecture, necrosis, tumor size, palpability, number of

excisions, surgical margin, hormone receptor status, HER2 status; distribution of

DCISionRT scores across the cohort; and identification of key driver(s) of treatment

recommendation based on geographic region of the investigator.

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.