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8110 Gatehouse Road, Falls Church, VA 22042

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

Adult

Status

Recruiting

Protocol Number

NCT03448926

Offered At

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

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