Opened to recruitment 04-Jul-2014. First patient recruited 01-Oct-2014
60 UK sites were open to recruitment
Story so far
The LORIS Trial is run by the Cancer Research UK Clinical Trials Unit at the University of Birmingham. University of Birmingham is also the Sponsor for the trial. Dr. Matthew Wallis, Consultant Radiologist at Cambridge University Hospitals is the Chief Investigator for the study. LORIS was open to recruitment for 6 years and has faced numerous challenges. As with the majority of surgical de-escalation trials, acceptance by the wider research community and patients takes time due to the long held ideology that more treatment is better than less. The trial has now randomized 181 patients and a number of patients have now completed their 4-years of follow-up. 60 sites were open to recruitment and additional hospitals and NHS Breast Screening Units hosted the LORIS Patient Awareness Poster and LORIS Information Leaflet which facilitates patient referrals to participating centers. There is a strong belief in the research community that LORIS represents a critical question that cannot be answered in any other way and the LORIS research teams are engaged and committed to the trial.
Closed for recruitment as of 31-Mar-2020
Patients recruited/accrual target
Challenges and opportunities
The LORIS Trial faced many challenges in patient recruitment in part due to entrenched ideology about how DCIS should be treated and also in the numbers of low-risk DCIS cases seen. We tried to overcome this through public awareness and communication workshops delivered by the Sussex Health Outcomes Research & Education in Cancer group. Research sites also faced difficulty in lack of support staff to offer research to patients, unfortunately this is a nationwide challenge. LORIS countered this by opening further sites to ensure patients have access to the trial.
The results of the Central Histopathology real time review process (local assessment vs central review), will provide robust data to inform on pathological assessment of DCIS and improve the quality of histological reporting. Blood samples and translational samples will be used to indicate any potential biomarkers and genetic patterns that will help us to identify in future which women can safely avoid surgery and tailor treatment options for future generations. The results of the trial will generate evidence regarding the safety of active monitoring for low risk DCIS and all patients to make an informed choice in their treatment in addition to considerable cost savings to the healthcare providers.