A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Participants with DCIS Following Breast Conserving Therapy

General Information

Age Group




Protocol Number


Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Inova Loudoun Hospital
44045 Riverside Pkwy
Leesburg, VA 20176

Inova Fair Oaks Medical Campus
3580 Joseph Siewick Drive
Fairfax, VA 22033

Inova Alexandria Hospital
4320 Seminary Road
Alexandria, VA 22304

Eligibility Information

  • Participant must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast. (LCIS) or other benign breast disease in addition to DCIS is acceptable.
  • Participant must have the DCISionRT™ Test ordered during routine participant care
  • Participant must be planning to undergo breast conserving surgery
  • Participant must be eligible to receive radiation and/or systemic treatment
  • Participant must be greater than 25 years old
  • Participant must have been diagnosed with DCIS within 120 days of consent
  • Additional eligibility in protocol

Ineligibility Information

  • Participant tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs are missing
  • Participant 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
  • Participant has been surgically treated with a mastectomy for primary DCIS
  • Participant has prior in situ or invasive breast cancer
  • Additional ineligibility in protocol

For more information, go to: https://clinicaltrials.gov/ct2/show/NCT03448926