Surgery versus Active Monitoring for LOw RISk Ductal Carcinoma in Situ (DCIS)
| ISRCTN | ISRCTN27544579 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27544579 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 16736 |
| Sponsor | University of Birmingham (UK) |
| Funder | Health Technology Assessment Programme; Grant Codes: 11/36/16 |
- 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
Contact information
Ms Claire Gaunt
Scientific
Scientific
Institute for Cancer Studies
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| C.H.Gaunt@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase III multicentre two-arm study with a built-in 2-year feasibility phase |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A Phase III Trial of Surgery versus Active Monitoring for LOw RISk Ductal Carcinoma in Situ (DCIS) |
| Study acronym | LORIS |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Ipsilateral invasive breast cancer free survival rate; Timepoint(s): 5 years |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 46 Years |
| Sex | Female |
| Target sample size at registration | 932 |
| Total final enrolment | 181 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 06/06/2014 |
| Date of final enrolment | 31/03/2020 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Institute for Cancer Studies
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
