Surgery versus Active Monitoring for LOw RISk Ductal Carcinoma in Situ (DCIS)

ISRCTN ISRCTN27544579
DOI https://doi.org/10.1186/ISRCTN27544579
Secondary identifying numbers 16736
Submission date
22/05/2014
Registration date
22/05/2014
Last edited
16/10/2023
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/trials/a-trial-comparing-surgery-with-active-monitoring-for-low-risk-dcis-loris

Contact information

Ms Claire Gaunt
Scientific

Institute for Cancer Studies
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email C.H.Gaunt@bham.ac.uk

Study information

Study designPhase III multicentre two-arm study with a built-in 2-year feasibility phase
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA Phase III Trial of Surgery versus Active Monitoring for LOw RISk Ductal Carcinoma in Situ (DCIS)
Study acronymLORIS
Study objectivesThe LORIS Trial aims to establish whether patients with newly diagnosed low risk DCIS can safely avoid surgery without detriment to their wellbeing (psychological and physical) and whether those patients who do require surgery can be identified by pathological and radiological means.
Ethics approval(s)14/WM/0083; First MREC approval date 28/04/2014
Health condition(s) or problem(s) studiedDuctal carcinoma in situ
InterventionComprehensive site training will be complimented by a patient-friendly DVD designed to ensure consistent and appropriate use of terminology. Patients will be randomised between standard surgery and active monitoring with annual mammography. Follow-up will be for a minimum of 10 years. Active Monitoring, Patients will be actively monitored by annual mammography.; Follow Up Length: 120 month(s); Study Entry : Registration and One or More Randomisations
Intervention typeOther
Primary outcome measureIpsilateral invasive breast cancer free survival rate; Timepoint(s): 5 years
Secondary outcome measuresNot provided at time of registration
Overall study start date06/06/2014
Completion date31/03/2030

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit46 Years
SexFemale
Target number of participantsPlanned Sample Size: 932; UK Sample Size: 932
Total final enrolment181
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment06/06/2014
Date of final enrolment31/03/2020

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Institute for Cancer Studies
Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Institute for Cancer studies
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

ROR logo "ROR" https://ror.org/03angcq70

Funders

Funder type

Government

Health Technology Assessment Programme; Grant Codes: 11/36/16
Government organisation / National government
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No
Other publications 14/10/2023 16/10/2023 Yes No

Editorial Notes

16/10/2023: Publication reference added.
01/05/2020: The following changes were made to the trial record:
1. The overall end date was changed from 05/06/2020 to 31/03/2030.
2. The recruitment end date was changed from 05/06/2020 to 31/03/2020.
3. The total final enrolment was added.
03/04/2019: The condition has been changed from "Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast" to "Ductal carcinoma in situ" following a request from the NIHR.