The PREDICT Registry for DCIS Patients With DCISionRT Testing
- Conditions
- DCIS
- Interventions
- Other: Treatment Recommendation SurveysDevice: 7-gene biosignature
- Registration Number
- NCT03448926
- Lead Sponsor
- PreludeDx
- Brief Summary
This is a prospective cohort study for patients diagnosed with ductal carcinoma in situ (DCIS) of the breast. The primary objective of the study is to create a de-identified database of patients, test results, treatment decisions and outcomes that can be queried to determine the utility of the DCISionRT™ test in the diagnosis and treatment of ductal carcinoma in situ of the breast.
- Detailed Description
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) with completion of a yearly follow-up form.
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 anticipates the participation of 25 to 100 sites within the United States with each site enrolling between 10 and 100 patients. The study is designed to collect information for up to 2,500 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Female
- Target Recruitment
- 2500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description DCIS Treatment Recommendation Surveys Patients must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast without evidence of invasive cancer (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable) DCIS 7-gene biosignature Patients must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast without evidence of invasive cancer (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable)
- Primary Outcome Measures
Name Time Method Percent of Cases with Changes in Treatment Recommendation From enrollment to the beginning of treatment. 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.
- Secondary Outcome Measures
Name Time Method Function of Tumor Factors 5 years 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).
Function of Tumor and Demographic Factors From enrollment to the beginning of treatment. 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).
Trial Locations
- Locations (15)
St. Joseph's Hospital Tampa
🇺🇸Tampa, Florida, United States
Arizona Center for Cancer Care
🇺🇸Phoenix, Arizona, United States
Sutter Institute for Medical Research
🇺🇸Sacramento, California, United States
Mills-Peninsula Medical Center
🇺🇸San Mateo, California, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
UC Health - Memorial Hospital, Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center at South Shore
🇺🇸South Weymouth, Massachusetts, United States
Comprehensive Breast Care
🇺🇸Troy, Michigan, United States
Maimonides Cancer Center
🇺🇸Brooklyn, New York, United States
Cleveland Clinic Akron General
🇺🇸Akron, Ohio, United States
Cleveland Clinic Foundation Taussig Cancer Institute
🇺🇸Cleveland, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Nashville Breast Center
🇺🇸Nashville, Tennessee, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States