A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with Ductal Carcinoma In Situ (DCIS) Following Breast Conserving Therapy to Determine the Clinical Utility of the DCISionRT Test in the Management of DCIS

Not Applicable

Recruiting

• Conditions: Ductal carcinoma in situ (DCIS) of the breast; Cancer - Breast

• Registration Number: ACTRN12621000695808
• Lead Sponsor: Prelude Australia Pty Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 1500

Inclusion Criteria

1.A clinical decision has been made to order the DCISionRT™ Test as part of routine patient care
2.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)
3.Patient must be consented within 120 days after surgery
4.Patient must be eligible for, or have already received breast conserving surgery
5.Patient must be eligible to receive radiation and/or systemic treatment
6.Patient must be female and greater than 25 years old
7.Patient must be able to provide informed consent

Exclusion Criteria

1.Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing
2.Patient has invasive breast cancer or evidence in the ipsilateral or contralateral breast of invasive breast cancer, including microinvasion, lymph node involvement, or Paget’s disease of the nipple
3.Patient has already been surgically treated with a mastectomy for primary DCIS
4.Patient has prior in situ or invasive breast cancer
5.Patient is pregnant

Study & Design

• Study Type: Observational
• Study Design: Not specified