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

Adults

Recruiting

NCT03448926

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

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

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