Trials Sponsors Conditions Drugs Pricing

Conditions

Li-Fraumeni syndrome

Outcome Measures

Primary Outcomes (1)

Cancer-free survival (CFS) as time between randomization and “cancer” event defined as histologically confirmed cancer diagnosis established during trial participation or death from any cause

Secondary Outcomes (8)

Tumor-free survival (TFS) as time between randomization and a “tumor” event including diagnosis of histologically confirmed cancer or clinically or radiologically detected benign or premalignant lesion identified during trial participation or death from any cause
Time from randomization to death from any cause during trial participation
Number and type of emerging cancers, including size, stage and histological grade at diagnosis
Treatment-emergent (serious) adverse events (AEs, SAEs)
Levels of metformin adherence described by the aggregated MARS-5 scores
+3 more secondary outcomes

Interventions

METFORMINType not reported

METFORMIN HYDROCHLORIDEType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
METFORMIN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
METFORMIN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM COATED TABLETS
View registry record
Formulated product
METFORMIN HYDROCHLORIDE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
ORAL SOLUTION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

METFORMIN
Named ingredient: Metformin
View registry record
METFORMIN
Named ingredient: Metformin
View registry record
METFORMIN HYDROCHLORIDE
Named ingredient: Metformin hydrochloride
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Child (0-17), Older Adult (65+)

You may qualify 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

Sponsors & Collaborators

Medizinische Hochschule Hannover
Otherlead

Study Sites (3)

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Dr. med. Christian Kratz+495115326711 kratz.christian@mh-hannover.de

Universitaetsklinikum Augsburg

Augsburg, 86156, Germany

Dr. Michaela Kuhlen+498214009306 michaela.kuhlen@uk-augsburg.de

Universitaetsklinikum Heidelberg AöR

Heidelberg, 69120, Germany

Dominik Sturm+496221561970

Central Study Contacts

Klinik für pädiatrische Hämatologie und Onkologie

+495115320 lfs-metformin.zks@mh-hannover.de

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

June 25, 2025

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-520714-63-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-11-01 06:27:29 UTC

Documents

D1_Protocol_2025-520714-63-00_geschwarzt

You may not qualify if:

Currently taking metformin
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
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 for cancer prevention in Li-Fraumeni Syndrome (LFS)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations