The PREDICT Registry:
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age30-85
SponsorPreludeDx
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Treatment recommendation surveys
Other interventionTreatment 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 biosignature
DeviceOrdering 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.
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: DCIS2 interventions
Trial outcomes
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.
Time frame
From enrollment to the beginning of treatment.Secondary outcomes
1
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 years2
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.Other outcomes
1
Distribution of DCISionRT scores across the cohort
Each patient will receive the following results from the DCISionRT test: Decision Score (DS, 0.8-10.0), Residual Risk subtype (DS 9.2).
Time frame
From enrollment to the beginning of treatment.2
Function of Geographic Region
Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of the geographic region of the investigator, type of institution, or type of treating physician.
Time frame
From enrollment to the beginning of treatment. Source ClinicalTrials.gov