Plain English Summary
Study website
Contact information
Type
Scientific
Contact name
Ms Claire Gaunt
ORCID ID
Contact details
Institute for Cancer Studies
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
C.H.Gaunt@bham.ac.uk
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
16736
Study information
Scientific title
A Phase III Trial of Surgery versus Active Monitoring for LOw RISk Ductal Carcinoma in Situ (DCIS)
Acronym
LORIS
Study hypothesis
The 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
Study design
Phase III multicentre two-arm study with a built-in 2-year feasibility phase
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Ductal carcinoma in situ
Intervention
Comprehensive 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 type
Other
Primary outcome measure
Ipsilateral invasive breast cancer free survival rate; Timepoint(s): 5 years
Secondary outcome measures
Not provided at time of registration
Overall study start date
06/06/2014
Overall study end date
31/03/2030
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type(s)
Patient
Age group
Adult
Lower age limit
46 Years
Sex
Female
Target number of participants
Planned Sample Size: 932; UK Sample Size: 932
Total final enrolment
181
Participant exclusion criteria
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)
Recruitment start date
06/06/2014
Recruitment end date
31/03/2020
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Institute for Cancer Studies
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Institute for Cancer studies
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme; Grant Codes: 11/36/16
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |