Surgery versus Active Monitoring for LOw RISk Ductal Carcinoma in Situ (DCIS)
- Conditions
- Ductal carcinoma in situCancerIntraductal carcinoma in situ
- Registration Number
- ISRCTN27544579
- Lead Sponsor
- niversity of Birmingham (UK)
- Brief Summary
2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37838682/ (added 16/10/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 181
1. Female, aged 46 years or above
2. Screendetected or incidental microcalcification (unilateral or bilateral)
3. Histologically confirmed diagnosis of nonhigh grade DCIS confirmed by local pathologist on either small volume
core biopsy or VACB (in accordance with the current NHSBSP Guidelines for Pathology Reporting in Breast Cancer
Screening)
4. DCIS diagnosed =90 days before registration
5. Able to give informed consent and comply with the trial schedule and completion of Patient Reported Outcome
questionnaires
6. Patient fit to undergo surgery
7. Written informed consent obtained
1. Previous diagnosis of invasive cancer or ipsilateral DCIS (previous surgically treated contralateral DCIS is permitted)
2. A mass lesion clinically on mammogram or on ultrasound scan (if performed) at the site of the microcalcification
before biopsy
3. Any serious and/or unstable preexisting medical, psychiatric, or other condition that would prevent compliance with
the trial or consent process
4. Recent onset ipsilateral bloodstained nipple discharge, unless cytology and/or Ultrasound Scan (USS) confirmed
concomitant duct ectasia
5. High risk group for developing breast cancer (as defined in current NICE guidelines for familial breast cancer, or due
to prior exposure to mantle field radiotherapy)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ipsilateral invasive breast cancer free survival rate; Timepoint(s): 5 years
- Secondary Outcome Measures
Name Time Method ot provided at time of registration