BridgeMD
Metformin for cancer prevention in Li-Fraumeni Syndrome (LFS)
EU CTIS ID: 2025-520714-63-00
What this study is testing
The primary objective is to demonstrate superiority of metformin (daily intake) on top of close cancer surveillance (metformin arm) regarding a prolonging of CFS compared to close cancer surveillance alone (control arm) in adolescents and adults with LFS.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male, female, inter/diverse participants (biological sex will be documented for randomization) aged ≥ 10 years
- LFS diagnosis confirmed by detection of a TP53 germline or postzygotic somatic P/LP variant
- Capable of understanding the consent process and participation in the trial
- Signed written informed consent by participant and both parents/ legal representatives (if applicable)
You likely can't join if
- Currently taking metformin
- Evidence of significant renal impairment, eGFR < 45ml/min/1.73m² or conditions like dehydratation, severe infections or shock that could affect renal function
- Liver failure, cirrhosis and/or aspartate transaminase or alanine transaminase >2.5 x upper limit of normal (ULN)
- Elevated risk of lactic acidosis such as current moderate to severe alcohol use disorder (AUD), congenital lactic acidosis, concurrent intake of carbonic anhydrase inhibitor (e.g. acetazolamide), acute metabolic acidosis
- Hypersensitivity to any of the components of the IMP metformin used and contained excipients
- Unwillingness or inability of participant to take part in the cancer surveillance programme (incl. WB-MRI)
See the full eligibility criteria
- Male, female, inter/diverse participants (biological sex will be documented for randomization) aged ≥ 10 years
- LFS diagnosis confirmed by detection of a TP53 germline or postzygotic somatic P/LP variant
- Capable of understanding the consent process and participation in the trial
- Signed written informed consent by participant and both parents/ legal representatives (if applicable)
- Currently taking metformin
- Evidence of significant renal impairment, eGFR < 45ml/min/1.73m² or conditions like dehydratation, severe infections or shock that could affect renal function
- Liver failure, cirrhosis and/or aspartate transaminase or alanine transaminase >2.5 x upper limit of normal (ULN)
- Elevated risk of lactic acidosis such as current moderate to severe alcohol use disorder (AUD), congenital lactic acidosis, concurrent intake of carbonic anhydrase inhibitor (e.g. acetazolamide), acute metabolic acidosis
- Hypersensitivity to any of the components of the IMP metformin used and contained excipients
- Unwillingness or inability of participant to take part in the cancer surveillance programme (incl. WB-MRI)
- Participation in another clinical trial with investigational drugs within five times the half-life of the investigational drug or relevant metabolites at the time of enrolment
- Metformin intake for more than 3 consecutive months within 2 years before randomization
- Current cancer diagnosis (detected previously or at baseline screening) , if feasible, rescreening should be offered at a later suitable date
- Current completion of cancer therapy < 6 months before randomization, if feasible, rescreening should be offered at a later suitable date
- Current type 2 DM
- Female participants who are pregnant or breastfeeding before randomization; if feasible, re-screening should be offered at a later suitable date. Exemptions during trial participation are detailed in table 5 in chapter 13.9.
- Gastro-intestinal condition (such as Short-Bowel Syndrome) that could affect uptake of metformin
- Concurrent illness that could result in life expectancy of <5 years
- History of one or more of the following cardiac conditions: a. Grade II severity according to the New York Heart Association Functional Classification (defined as symptomatic at less than ordinary levels of activity). b. Ischemic cardiac event including myocardial infarction within 3 months prior to randomization c. Uncontrolled cardiac disease, including unstable angina pectoris, uncontrolled hypertension (i.e., sustained systolic BP > 160mmHg or diastolic BP > 90mmHg); or other known acute cardio-respiratory illness like respiratory failure or recent myocardial infarction that could lead to tissue hypoxia
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.