Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2018-02-27
2035-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
Treatment Recommendation Surveys
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 biosignature
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.
Interventions
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Treatment Recommendation Surveys
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 biosignature
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 Criteria
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Inclusion Criteria
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
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.
30 Years
85 Years
FEMALE
No
Sponsors
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PreludeDx
INDUSTRY
Responsible Party
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Principal Investigators
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Troy Bremer, PhD
Role: PRINCIPAL_INVESTIGATOR
PreludeDx
Pat W Whitworth, MD
Role: STUDY_CHAIR
PreludeDx
Rachel Rabinovitch, MD
Role: STUDY_CHAIR
University of Colorado, Denver
Pat Borgen, MD
Role: STUDY_CHAIR
Maimonides Medical Center
Locations
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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
St. Joseph's Hospital Tampa
Tampa, Florida, 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
Countries
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Central Contacts
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Facility Contacts
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Daniel Reed, DO
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Christopher Biggs, MD
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Marianne Mildenberger, MD
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Terry Lee, MD
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Jason Samuelian, DO
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Coral Quiet, MD
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Scott Tannehill, MD
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Gregory Maggass, MD
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Luci Chen, MD
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Robert Kuske, MD
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Sommer Guina, DO
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Kaleigh Doke, MD
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Tari King, MD
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Thanh Barbie, MD
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Laura Dominici, MD
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Jean Landry, NP
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Lara Novak, PA
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Olivia Donnelly, NP
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Faina Nakhlis, MD
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Anna Weiss, MD
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Katie Anderson, PA
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Katherina Zabicki Calvillo, MD
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Camile Borland, PA
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Erin Healy, MD
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Elizabeth Bonefas, MD
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Alastair Thompson, MD
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Stacey Carter, MD
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References
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Shah C, Whitworth P, Vicini FA, Narod S, Gerber N, Jhawar SR, King TA, Mittendorf EA, Willey SC, Rabinovich R, Gold L, Brown E, Patel A, Vargo J, Barry PN, Rock D, Friedman N, Bedi G, Templeton S, Brown S, Gabordi R, Riley L, Lee L, Baron P, Majithia L, Mirabeau-Beale KL, Reid VJ, Hirsch A, Hwang C, Pellicane J, Maganini R, Khan S, MacDermed DM, Small W, Mittal K, Borgen P, Cox C, Shivers SC, Bremer T. The Clinical Utility of a 7-Gene Biosignature on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery: An Updated Analysis of the DCISionRT(R) PREDICT Study. Ann Surg Oncol. 2024 Sep;31(9):5919-5928. doi: 10.1245/s10434-024-15566-5. Epub 2024 Jun 25.
Dabbs D, Mittal K, Heineman S, Whitworth P, Shah C, Savala J, Shivers SC, Bremer T. Analytical validation of the 7-gene biosignature for prediction of recurrence risk and radiation therapy benefit for breast ductal carcinoma in situ. Front Oncol. 2023 May 19;13:1069059. doi: 10.3389/fonc.2023.1069059. eCollection 2023.
Vicini FA, Mann GB, Shah C, Weinmann S, Leo MC, Whitworth P, Rabinovitch R, Torres MA, Margenthaler JA, Dabbs D, Savala J, Shivers SC, Mittal K, Warnberg F, Bremer T. A Novel Biosignature Identifies Patients With DCIS With High Risk of Local Recurrence After Breast Conserving Surgery and Radiation Therapy. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):93-102. doi: 10.1016/j.ijrobp.2022.06.072. Epub 2022 Sep 15.
Warnberg F, Karlsson P, Holmberg E, Sandelin K, Whitworth PW, Savala J, Barry T, Leesman G, Linke SP, Shivers SC, Vicini F, Shah C, Weinmann S, Mann GB, Bremer T. Prognostic Risk Assessment and Prediction of Radiotherapy Benefit for Women with Ductal Carcinoma In Situ (DCIS) of the Breast, in a Randomized Clinical Trial (SweDCIS). Cancers (Basel). 2021 Dec 3;13(23):6103. doi: 10.3390/cancers13236103.
Shah C, Bremer T, Cox C, Whitworth P, Patel R, Patel A, Brown E, Gold L, Rock D, Riley L, Kesslering C, Brown S, Gabordi R, Pellicane J, Rabinovich R, Khan S, Templeton S, Majithia L, Willey SC, Warnberg F, Gerber NK, Shivers S, Vicini FA. Correction to: The Clinical Utility of DCISionRT(R) on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery. Ann Surg Oncol. 2021 Dec;28(Suppl 3):878. doi: 10.1245/s10434-021-10138-3. No abstract available.
Other Identifiers
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Ext00000206
Identifier Type: -
Identifier Source: org_study_id
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