A Phase III Trial of Surgery versus Active Monitoring for LOw RISk Ductal Carcinoma in Situ (DCIS)

niversity of Birmingham (UK)0 个研究点目标入组 181 人开始时间: 2014年5月22日最近更新: 2023年10月30日

适应症

试验速览

2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37838682/ (added 16/10/2023)

•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
•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)

发起方

niversity of Birmingham (UK)