What this study is
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.
What's being tested
- Treatment Recommendation Surveys
Intervention · OTHER
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
Intervention · DEVICE
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.
Study details
- 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
- Sponsor
- PreludeDx
- Conditions
- DCIS
- Enrolling
- 3,000 people
- Starts
- 2018-02-27
- Est. completion
- 2035-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 30 Years – 85 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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.
- Patient must be 30 to 85 years old.
- Patient must have tumor size of less than 6 cm.
- Patient must have been diagnosed with DCIS within 120 days of consent.
You can't join if
- 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.
- Patient has a prior history of in-field radiation in the ipsilateral breast.
- Patient has had prior systemic endocrine or chemotherapy prior to testing.
- Patient is pregnant.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (15)
15 openArizona Center for Cancer Care
Phoenix, Arizona, United States
- Penny Labriola · Contact480-270-5311penny.labriola@arizonaccc.com
- Shakila Rajack, MBBS · Contact480-278-8300shakila.rajack@arizonaccc.com
- Daniel Reed, DO · Contact
- Christopher Biggs, MD · Contact
- Marianne Mildenberger, MD · Contact
- Terry Lee, MD · Contact
- Jason Samuelian, DO · Contact
- Coral Quiet, MD · Contact
- Scott Tannehill, MD · Contact
- Gregory Maggass, MD · Contact
- Luci Chen, MD · Contact
- Robert Kuske, MD · Contact
- Anushka Patel, MD · Contact
- Steven Sckolnik, MD · Contact
- Farley Yang, MD · Contact
- Sommer Guina, DO · Contact
- Linda Liu, MD · Contact
- S. Brenda Moorthy, DO · Contact
- Kimberli Cox, MD · Contact
- Lise Walker, MD · Contact
- Janice Angeles, DO · Contact
- Selyne Samuel, MD · Contact
- Noemi Sigalove, MD · Contact
- Samuel Day, MD · Contact
- Justin Famoso, MD · Contact
- Ashley Albert, MD · Contact
- Samuel E Day, MD · Contact
RecruitingSutter Institute for Medical Research
Sacramento, California, United States
- Stephanie Brown, RN · Contact916-717-5074brownsa2@sutterhealth.org
- Michele Guillen · Contact916-887-4656guillem1@sutterhealth.org
- Lauren Strickland, DO · Contact
- John S Lee, MD · Contact
- Lisa Guirguis, MD · Contact
- Janice Ryu, MD · Contact
- Carlin Hauck, MD · Contact
- Anthony Pu, MD · Contact
- Harvey Wolkov, MD · Contact
- Nitin Rohatgi, MD · Contact
- Melissa Williams, MD · Contact
RecruitingMills-Peninsula Medical Center
San Mateo, California, United States
- Stephanie Casal · Contact650-696-4814casalsl@sutterhealth.org
- Al Taira, MD · Contact
- Amanda Wheeler, MD · Contact
- Andrea Metkus, MD · Contact
- Dhara Macdermed, MD · Contact
RecruitingUniversity of Colorado Denver
Aurora, Colorado, United States
- Chelsea Schaefer · Contact720-848-0608chelsea.schaefer@cuanschutz.edu
- Robin Swing · Contact720-848-0607robin.swing@cuanschutz.edu
- Rachel Rabinovitch, MD · Contact
- Christine Fisher, MD, MPH · Contact
- Sameer Nath, MD · Contact
- Adam Mueller, MD, PhD · Contact
- David Binder, MD, PhD · Contact
- Narine Wandrey-Bhardwaj, MD · Contact
- Sara Zakem, MD · Contact
- Doug Holt, MD · Contact
- Marina Moskalenko, MD · Contact
- Jay Shiao, MD, MPH, MSc · Contact
- Kareem Fakhoury, MD · Contact
RecruitingUC Health - Memorial Hospital, Colorado Springs
Colorado Springs, Colorado, United States
- Lisa Deschaine · Contactalicia.deschaine@uchealth.org
- Caralyn Henderson · Contactcaralyn.henderson@uchealth.org
- Jane Ridings, MD · Contact
- Jeffrey Olsen, MD · Contact
- Kaleigh Doke, MD · Contact
- Rhonda Hoppes, MD · Contact
RecruitingSt. Joseph's Hospital Tampa
Tampa, Florida, United States
- Kate Colgain, RN · Contact813-356-7168katelynn.colgain@baycare.org
- Sarah Moore, RN · Contact813-707-2155sarah.moore@baycare.org
- Robert Gabordi, MD · Contact
RecruitingDana-Farber Cancer Institute
Boston, Massachusetts, United States
- Caroline Frommson, CRCII · Contact617-525-6529caroline_fromson@dfci.harvard.edu
- Dan Desantis · Contact617-632-5597stephen_desantis@dfci.harvard.edu
- Tari King, MD · Contact
- Elizabeth Mittendorf, MD, PhD · Contact
- Thanh Barbie, MD · Contact
- Laura Dominici, MD · Contact
- Margaret Duggan, MD · Contact
- Jennifer Bellon, MD · Contact
- Katie McLean, PA · Contact
- Jean Landry, NP · Contact
- Jenna Macone, PA · Contact
- Lara Novak, PA · Contact
- Olivia Donnelly, NP · Contact
- Faina Nakhlis, MD · Contact
- Anna Weiss, MD · Contact
- Mehra Golshan, MD · Contact
- Esther Rhei, MD · Contact
- Julia Wong, MD · Contact
- Rinaa Punglia, MD · Contact
- Laura Warren, MD · Contact
- Katie Anderson, PA · Contact
- Katherina Zabicki Calvillo, MD · Contact
- Suniti Nimbkar, MD · Contact
- Alison Laws, MD · Contact
- Olga Kantor, MD · Contact
- Christina Minami, MD · Contact
- Bryan Danilchuk, PA · Contact
- Camile Borland, PA · Contact
RecruitingDana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth, Massachusetts, United States
- Caroline Fromson · Contact617-632-6821caroline_fromson@dfci.harvard.edu
- Nicole Hixon, RN · Contact781-624-4795Nicole_Hixon@DFCI.HARVARD.EDU
- Suniti Nimbkar, MD · Contact
- Katherina Zabicki Calvillo, MD · Contact
- Anna Weiss, MD · Contact
RecruitingComprehensive Breast Care
Troy, Michigan, United States
- Michelle Khan · Contact248-243-3696mkhan@compbreastcare.com
- Devine Numan · Contact248-602-4387dnuman@compbreastcare.com
- Linsey Gold, DO · Contact
- Pamela Johnson, MD · Contact
- Pamela Benitez, MD · Contact
- Eric Brown, MD · Contact
- Ashley Richardson, DO · Contact
RecruitingMaimonides Cancer Center
Brooklyn, New York, United States
- Carin Zelkowitz · Contact718-765-2579CZelkowitz@maimonidesmed.org
- Bina Valenzano · Contact718-765-2693bvalenzano@maimonidesmed.org
- Fleure Gallant, MD · Contact
- Donna M Manasseh, MD · Contact
- Charusheela Andaz, MD · Contact
- Patrick Borgen, MD · Contact
- David Berlach, MD · Contact
RecruitingCleveland Clinic Akron General
Akron, Ohio, United States
- Joelle Sigmond, BSN, RN · Contact330-344-6348sigmonj@ccf.org
- Wendy Catchpole · Contact330-344-6348catchpw@ccf.org
- Camille Berriochoa, MD · Contact
- Andrew Fenton, MD · Contact
- Amanda Mendiola, MD · Contact
- Mary Murray, MD · Contact
- Mitchel Fromm, MD · Contact
- Susan Hong, MD · Contact
- Ashok Ramaligam, MD · Contact
RecruitingCleveland Clinic Foundation Taussig Cancer Institute
Cleveland, Ohio, United States
- Julie Benchea · Contact216-445-9925benchej2@ccf.org
- Robin Davis · Contact216 444-5573davisr16@ccf.org
- Chirag Shah, MD · Contact
- Rahul Tendulkar, MD · Contact
- Sheen Cherian, MD · Contact
RecruitingThe Ohio State University
Columbus, Ohio, United States
- Sohyun McElroy · Contact614-685-7050Sohyun.McElroy@osumc.edu
- Jean Koutou · Contact614-293-5637JeanMartial.KoutouEssan@osumc.edu
- Saechan Jhawar, MD · Contact
- Julia White, MD · Contact
- Jose Bazan, MD · Contact
- Sasha Beyer, MD, PhD · Contact
- Erin Healy, MD · Contact
RecruitingNashville Breast Center
Nashville, Tennessee, United States
- Kristie Appleton · Contact615-620-5535 ext. 4310kristie@nashvillebreastcenter.com
- Pat Whitworth, MD · Contact
- Julian Heitz, MD · Contact
RecruitingBaylor College of Medicine
Houston, Texas, United States
- Brian Menegaz · Contact713-798-2317menegaz@bcm.edu
- Huma Javaid · Contact713-798-8058hjavaid@bcm.edu
- Elizabeth Bonefas, MD · Contact
- Alastair Thompson, MD · Contact
- Stacey Carter, MD · Contact
Recruiting
Study team
Sponsor
PreludeDx
Study ID Ext00000206
Principal investigator
Troy Bremer, PhD
PreludeDx
Study chair
Pat W Whitworth, MD
PreludeDx
Study chair
Rachel Rabinovitch, MD
University of Colorado, Denver
Study chair
Pat Borgen, MD
Maimonides Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.