Surgery versus Active Monitoring for LOw RISk Ductal Carcinoma in Situ (DCIS)
| ISRCTN | ISRCTN27544579 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27544579 |
| 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
- 20/08/2026
- 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
Dr Jessica Foster
Scientific
Scientific
Cancer Research UK Clinical Trials Unit (CRCTU)
School of Medical Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| LORIS@trials.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 |
| 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 | Mixed |
| Lower age limit | 46 Years |
| Upper age limit | 100 Years |
| Sex | Female |
| Target sample size at registration | 932 |
| Total final enrolment | 181 |
| Key inclusion criteria | Current inclusion criteria as of 16/06/2026: 1. Female, aged 46 years or above 2. Screendetected or incidental microcalcification 3. Histologically confirmed diagnosis of non-high-grade DCIS confirmed by local pathologist (for both breasts if bilateral disease) by: Small volume core biopsy and vacuum-assisted core biopsy (VACB) Or VACB alone as a first-line diagnostic approach Or Small volume biopsy or VACB plus open diagnostic surgical biopsy (without clear margins) Or Open diagnostic surgical biopsy (without clear margins) (in accordance with the current NHSBSP Guidelines for Pathology Reporting in Breast Cancer Screening) 4. DCIS diagnosed ≤90 days before registration 5. Bilateral disease is permitted if both sides are confirmed to be non-high-grade DCIS by local pathologist and the diagnosis is made within the same treatment episode 6. Able to give informed consent and comply with the trial schedule 6. Patient fit and willing to undergo surgery 7. Written informed consent obtained Previous 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 | Current exclusion criteria as of 16/06/2026: 1. Previous or current diagnosis of invasive cancer or previous ipsilateral DCIS (previous surgically treated contralateral DCIS is permitted) 2. A mass lesion clinically or on imaging which has not been proven on biopsy to be a specific benign lesion 3. Surgical procedure with curative intent (even if clear margins have not been achieved) 4. Unequivocal comedo necrosis observed 5. Any serious and/or unstable pre-existing condition that would prevent compliance with the trial or the consent process 6. Recent-onset ipsilateral bloodstained nipple discharge without benign explanation 7. 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) Previous 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
Cancer Research UK Clinical Trials Unit (CRCTU)
School of Medical Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
England
School of Medical Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
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 | |
| Plain English results | Early results | 20/08/2026 | No | Yes |
Editorial Notes
20/08/2026: Cancer Research UK plain English results link added.
16/06/2026: The inclusion/exclusion criteria, study participating centres and contact details were updated.
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.
