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Principal Investigator - Prof Val Jenkins

Principal Investigator - Prof Dame Lesley Fallowfield

Researcher - Lucy Matthews

Data Manager - Shirley May

Funder: NIHR HTA

Sponsor: University of Birmingham

The introduction of the mammographic breast screening programme in the UK resulted in a dramatic increase in the diagnosis of Ductal Carcinoma in situ (DCIS). DCIS accounts for approximately 20% of breast 'cancers' detected by breast screening. A diagnosis of DCIS means there are abnormal cells in the milk ducts of the breast that have not invaded the surrounding breast tissue.

DCIS is visualised as specks of white (calcium) seen on mammograms. Pathologically it can be divided into 3 grades - high, intermediate or low. High grade DCIS is more likely to turn into breast cancer, and so it is treated as though it is breast cancer. Low and low/intermediate grade DCIS is different and doctors are uncertain if it would ever become invasive breast cancer. Currently, all DCIS is treated by surgery.

Between August 2014 and March 2020, the Low Risk DCIS (LORIS) Trial recruited 181 patients with low or intermediate grade DCIS. Patients were randomised to either no surgical intervention (active monitoring) or standard treatment which is surgery.

Quality of life (QoL) is a secondary outcome measure of the LORIS Trial. Participants completed baseline QoL questionnaires prior to randomisation. Then 3 times a year (3, 6 & 12 months) for the first year and then annually until 5 years.

The questionnaires asked about:

In addition, the impact that either active monitoring or surgery had on:

A subset of patients participated in a telephone interview to explore their feelings about the trial.

The QoL data are being analysed and will be published in 2026.

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