LFS Studies

This is a list of active projects and studies that include people with LFS. If you are aware of a project that we’re missing please let us know! The aim is to be as comprehensive as possible.

MILI – Metformin In Li Fraumeni System

Status: Recruiting
Details: This is the first clinical trial in which people with Li Fraumeni Syndrome will be taking the anti-diabetic drug metformin to see if it reduces the incidence of cancer. Previously small studies have looked at metformin in LFS to assess biological changes in cells, and to see if there were any safety concerns (there weren’t – they had the same kind of reactions as people who take the medicine for type II diabetes). The MILI trial has two arms – one set of people will be randomly selected to take metformin twice a day and have annual whole-body MRI and other screening, the second set of people will get the whole body MRI and screening only. Having two sets of people means that at the end of the trial we can compare how many got cancer in each group and therefore judge whether metformin made a difference or not.

The study is currently open at two sites, Oxford and Nottingham, with several other sites in set up such as Guys and St Thomas and Cambridge.

Who can join: The MILI trial is for adults who have a confirmed LFS TP53 variant and who are not currently suffering from cancer.

LiFTS – Li Fraumeni over Time Study

Status: Now recruiting.
Details: The aim of this project is to understand the biology of living with LFS. Specifically, to understand why the frequency of cancer and the age at which it occurs varies depending on where the cancer arises, and why some mutations in TP53 are associated with a higher risk of developing cancer than others. To do this, sophisticated new methods will be used to analyse the alterations in the DNA of cells that occur during life – taking samples from volunteers over a number of years and tracking the changes over time. The ultimate goal is to improve our understanding of cancer development and to improve the lives of LFS patients.
Who can join: People with LFS, including those without a confirmed TP53 variant, and members of their immediate family (brothers, sisters, parents). Children and adults are accepted. No drugs or other interventions are used – this is just about collecting tissue samples (blood, swabs inside the mouth etc). To join please email us: lifts@tp53.org.uk.


Status: Now recruiting.
Details: This is a follow on to the original SIGNIFY study which showed that whole-body MRI was effective in identifying cancer in people with LFS before they even had symptoms. The SIGNIFIED project aims to add to the evidence on the value of WBMRI for people with LFS. It will generate data on changes in the quality of life, as well as being used to create a model to show that WBMRI is cost-effective and feasible across the whole of the NHS. The study aims to recruit 50 LFS patients over the, and to offer them WBMRI, once at the start of the study and a follow-up 12 months later.
Who can join: Participants, who should not have had cancer in the previous 5 years, will also be asked to complete a health questionnaire at each of their scans. The study is based at the Royal Marsden Hospital, but potentially participants may take part in other centres if not close to London. To join please contact Dr Elena Cojocaru (Elena.cojocaru@rmh.nhs.uk).

ICED – Inherited cancers – early diagnosis study

Status: Now recruiting.
Details: The aim of this study is to develop a liquid biopsy (blood and/or urine) test that can detect cancer early in people with an inherited cancer predisposition syndrome. The project will look at different predisposition syndromes, including LFS and Lynch Syndrome. Recruited patients will give a blood and urine sample every 6 months, during a period of 12 months (up to 3X). The analysis of the blood and urine will be matched with symptom questionnaires and any scans or other surveillance that the patient receives. Being able to detect cancer early, while it is still easily treated, would be a major advance for people with LFS.
Who can join: Adults with a confirmed LFS variant of TP53 and who have not had cancer in the previous five years. To join please contact ICED@rmh.nhs.uk