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The PREDICT Registry for DCIS Patients With DCISionRT Testing (PREDICT)

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ClinicalTrials.gov Identifier: NCT03448926
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : April 6, 2021
Sponsor:
Collaborator:
University of South Florida
Information provided by (Responsible Party):
PreludeDx

Tracking Information
First Submitted Date February 16, 2018
First Posted Date February 28, 2018
Last Update Posted Date April 6, 2021
Actual Study Start Date February 27, 2018
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2018)
Percent of Cases with Changes in Treatment Recommendation [ Time Frame: 5 years ]
The study will collect details on physician treatment recommendations before and after availability of the genomic test (DCISionRT) results. The data elements include type of surgery (lumpectomy, therapeutic mastectomy, contralateral prophylactic mastectomy), type of radiation therapy (none, IORT, APBI, whole breast RT) and endocrine therapy (yes, no). The main measure will be percent of cases in which treatment recommendations are changed after the test results become available.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 27, 2018)
  • Function of Demographic Factors [ Time Frame: 5 years ]
    Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of demographic factors (age groups <40, 40-50 and >50; ethnicity; family history)
  • Function of Tumor Factors [ Time Frame: 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 27, 2018)
  • Distribution of DCISionRT scores across the cohort [ Time Frame: 5 years ]
    Each patient will receive the following results from the DCISionRT test: Risk Score (0 - 10.0), Risk Category Low (<=3.0) or Elevated (>3.0), Risk Prognosis with Breast Conserving Therapy Alone (0 - 40%) and Risk Prognosis with Breast Conserving Therapy and Radiation (0 - 40%).
  • Function of Geographic Region [ Time Frame: 5 years ]
    Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of the geographic region of the investigator.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title The PREDICT Registry for DCIS Patients With DCISionRT Testing
Official Title A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients With DCIS Following Breast Conserving Therapy
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study 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.
Condition DCIS
Intervention Diagnostic Test: DCISionRT Test
The Prelude DCISionRT Test was developed by Prelude Corporation and is performed at its CLIA laboratory facility. The biomarkers used to evaluate the biologic signature of DCIS tissue are based on over a decade of research including the University of California, San Francisco, Yale University as well as Prelude Corporation. The test is prognostic for 10-year recurrence risk and predicts RT treatment benefit for invasive breast cancer. The laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing and is accredited by the College of American Pathologists (CAP).
Study Groups/Cohorts DCIS
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)
Intervention: Diagnostic Test: DCISionRT Test
Publications * Bremer et al. Cancer Research. Feb 2017. Vol 77 Issue 4 Supp. SABCS16-S5-0.1

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 27, 2018)
2500
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2033
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria

  • 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 planning to undergo breast conserving surgery
  • Patient must be eligible to receive radiation and/or systemic treatment
  • Patient must be greater than 25 years old
  • Patient must have been diagnosed with DCIS within 120 days of consent
  • Patient must be able to provide informed consent

Exclusion criteria

  • 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 a mastectomy for primary DCIS
  • Patient has prior in situ or invasive breast cancer
  • Patient is pregnant
  • Patient was previously enrolled onto this registry
Sex/Gender
Sexes Eligible for Study: Female
Ages 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Steven C Shivers, PhD 813-215-1749 sshivers@preludedx.com
Contact: Mary Kay Hardwick 510-682-6256 mkhardwick@comcast.net
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03448926
Other Study ID Numbers 20172841
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party PreludeDx
Study Sponsor PreludeDx
Collaborators University of South Florida
Investigators
Principal Investigator: Charles E Cox, MD University of South Florida
Principal Investigator: Rakesh R Patel, MD Good Samaritan Hospital
Principal Investigator: Pat Whitworth, MD Nashville Breast Center
PRS Account PreludeDx
Verification Date April 2021