Li-Fraumeni syndrome

Last reviewed

🖨 Print for my doctorAdvocacy Hub →
ORPHA:524OMIM:609265C97
Who is this for?
Show terms as
9Active trials16Specialists8Treatment centers

Where are you in your journey?

UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
Report missing data

Overview

Li-Fraumeni syndrome (LFS), also known as SBLA syndrome (sarcoma, breast, leukemia, and adrenal gland cancer syndrome), is a rare hereditary cancer predisposition disorder caused by germline pathogenic variants in the TP53 tumor suppressor gene located on chromosome 17p13.1. The TP53 gene encodes the p53 protein, often called the 'guardian of the genome,' which plays a critical role in regulating cell division, DNA repair, and programmed cell death (apoptosis). When this gene is dysfunctional, cells with damaged DNA can proliferate unchecked, dramatically increasing the risk of developing multiple types of cancer throughout life. Li-Fraumeni syndrome affects multiple body systems and is characterized by an exceptionally high lifetime cancer risk, estimated at approximately 70% in males and nearly 100% in females. The core spectrum of cancers includes soft tissue sarcomas, osteosarcomas, premenopausal breast cancer, brain tumors (particularly gliomas and choroid plexus carcinomas), adrenocortical carcinomas, and acute leukemia. However, individuals with LFS may develop virtually any type of cancer. A hallmark feature is the early age of onset — many affected individuals develop their first cancer in childhood or young adulthood — and there is a significantly elevated risk of developing multiple primary cancers over a lifetime. Adrenocortical carcinoma in childhood is particularly suggestive of this syndrome. There is currently no cure for Li-Fraumeni syndrome. Management focuses on intensive cancer surveillance protocols, often referred to as the 'Toronto Protocol,' which include whole-body MRI, brain MRI, breast MRI, abdominal and pelvic ultrasound, and regular blood work to detect cancers at the earliest possible stage. Radiation therapy is generally avoided or minimized when possible due to the increased risk of radiation-induced secondary malignancies in individuals with TP53 mutations. Genetic counseling is essential for affected families. Risk-reducing mastectomy may be considered for women with LFS given the very high breast cancer risk. Research into targeted therapies and chemoprevention strategies is ongoing.

Clinical phenotype terms— hover any for plain English:

Breast carcinomaHP:0003002LeukemiaHP:0001909OsteosarcomaHP:0002669RhabdomyosarcomaHP:0002859EpendymomaHP:0002888Adrenocortical carcinomaHP:0006744Neoplasm of the gastrointestinal tractHP:0007378AstrocytomaHP:0009592Stomach cancerHP:0012126Glioblastoma multiformeHP:0012174Central primitive neuroectodermal tumorHP:0030070Choroid plexus carcinomaHP:0030392Neoplasm of the central nervous systemHP:0100006Colorectal polyposisHP:0200063MedulloblastomaHP:0002885Thyroid carcinomaHP:0002890
Inheritance

Autosomal dominant

Passed on from just one parent; each child has about a 50% chance of inheriting it

Age of Onset

Variable

Can begin at different ages, from infancy through adulthood

Orphanet ↗OMIM ↗NORD ↗

FDA & Trial Timeline

10 events
Apr 2026Clinical Genetics Branch Eligibility Screening Survey

National Cancer Institute (NCI)

TrialNOT YET RECRUITING
Feb 2025Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer

Sir Mortimer B. Davis - Jewish General Hospital

TrialRECRUITING
Apr 2024CfDNA in Hereditary And High-risk Malignancies 2

University Health Network, Toronto

TrialRECRUITING
Mar 2024Video Capsule Examination in Patients With Lynch Syndrome

Royal Marsden NHS Foundation Trust — NA

TrialRECRUITING
Dec 2023Arsenic Trioxide Combined With Chemotherapy for the Treatment of p53-mutated Pediatric Cancer

Yang Li — PHASE2

TrialRECRUITING
Nov 2022Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling

M.D. Anderson Cancer Center

TrialRECRUITING
Sep 2020Li-Fraumeni & TP53 (LiFT UP): Understanding and Progress

Dana-Farber Cancer Institute

TrialRECRUITING
Jul 2020Registry of Li Fraumeni and Li Fraumeni Like Syndromes

Istituto Ortopedico Rizzoli

TrialRECRUITING
Sep 2019Li-Fraumeni Syndrome/TP53 Biobank

Abramson Cancer Center at Penn Medicine

TrialRECRUITING
Jun 2016Li-Fraumeni Syndrome Imaging Study

The Hospital for Sick Children — NA

TrialENROLLING BY INVITATION

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

No FDA-approved treatments are currently listed for Li-Fraumeni syndrome.

9 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.

View clinical trials →

Clinical Trials

9 recruitingView all trials with filters →
Phase 21 trial
Arsenic Trioxide Combined With Chemotherapy for the Treatment of p53-mutated Pediatric Cancer
Phase 2
Actively Recruiting
PI: Yang Li, Professor (Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Unive) · Sites: Guangzhou, Guangdong · Age: 018 yrs
N/A4 trials
Video Capsule Examination in Patients With Lynch Syndrome
N/A
Actively Recruiting
PI: Richard Lee, PhD (Royal Marsden NHS Foundation Trust) · Sites: London, (Select) · Age: 1899 yrs
Li-Fraumeni Syndrome Imaging Study
N/A
Enrolling by Invitation
PI: Andrea Doria, MD (The Hospital for Sick Children) · Sites: Toronto, Ontario · Age: 018 yrs
Clinical and Genetic Studies of Li-Fraumeni Syndrome
N/A
Actively Recruiting
PI: Payal P Khincha, M.D. (National Cancer Institute (NCI)) · Sites: Bethesda, Maryland; Bethesda, Maryland
Screening With Whole Body MRI For Detection Of Primary Tumors In Children And Adults With Li-Fraumeni Syndrome (LFS) And Other Cancer Predisposition Syndromes
N/A
Active
PI: Allison O'Neill, MD (Dana-Farber Cancer Institute) · Sites: Boston, Massachusetts; New York, New York +1 more
Other4 trials
Registry of Li Fraumeni and Li Fraumeni Like Syndromes
Actively Recruiting
PI: Luca Sangiorgi, MSc (Istituto Ortopedico Rizzoli) · Sites: Bologna, Emilia-Romagna; Bologna, Emilia-Romagna
Li-Fraumeni & TP53 (LiFT UP): Understanding and Progress
Actively Recruiting
PI: Judy E Garber, MD, MPH (Dana-Farber Cancer Institute) · Sites: Boston, Massachusetts; Boston, Massachusetts +1 more
Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling
Actively Recruiting
PI: Banu Arun (M.D. Anderson Cancer Center) · Sites: Houston, Texas
Li-Fraumeni Syndrome/TP53 Biobank
Actively Recruiting
PI: Kara N Maxwell, MD, PhD (University of Pennsylvania) · Sites: Philadelphia, Pennsylvania; Phildelphia, Pennsylvania

Specialists

16 foundView all specialists →
AM
Allison O'Neill, MD
Specialist
PI on 3 active trials1 Li-Fraumeni syndrome publication
SM
Sharon A Savage, M.D.
Bethesda, Maryland
Specialist

Rare Disease Specialist

PI on 7 active trials
KM
Kim E. Nichols, MD
Memphis, Tennessee
Specialist

Rare Disease Specialist

PI on 2 active trials
PM
Payal P Khincha, M.D.
Bethesda, Maryland
Specialist

Rare Disease Specialist

PI on 3 active trials
PM
Paul M Hwang, M.D.
Specialist
PI on 2 active trials
LP
Laura C Hernández Ramírez, MD, PhD
Mexico City, Mexico City
Specialist

Rare Disease Specialist

PI on 1 active trial
VP
Vanessa Petry
Specialist
PI on 1 active trial
RE
Rosalind Eeles
Specialist
PI on 1 active trial
AG
Angela George
Specialist
PI on 1 active trial
BA
Banu Arun
HOUSTON, TX
Specialist
PI on 1 active trial
CA
Christina M Annunziata
BETHESDA, MD
Specialist
PI on 2 active trials
JG
Judy E Garber
BRENTWOOD, TN
Specialist
PI on 1 active trial
KM
Kara N Maxwell
CANTON, MI
Specialist
PI on 1 active trial
AD
Andrea Doria
CERRITOS, CA
Specialist
PI on 1 active trial
YL
Yang Li
Specialist
PI on 1 active trial
NS
Nicholas J Schork
Specialist
PI on 1 active trial

Treatment Centers

8 centers
⚗️ Trial Site

National Institutes of Health Clinical Center

📍 Bethesda, Maryland

👤 Payal P Khincha, M.D.

👤 Christopher Grunseich, M.D.

⚗️ Trial Site

National Cancer Institute - Shady Grove

📍 Bethesda, Maryland

👤 Payal P Khincha, M.D.

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

Travel Grants

No travel grants are currently matched to Li-Fraumeni syndrome.

Search all travel grants →NORD Financial Assistance ↗

Community

Open Li-Fraumeni syndromeForum →

No community posts yet. Be the first to share your experience with Li-Fraumeni syndrome.

Start the conversation →

Latest news about Li-Fraumeni syndrome

1 articles
Clinical trialCLINICALTRIALSMar 26, 2026
Trial Now Recruiting: Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System (NCT01143454)
Researchers at the National Heart, Lung, and Blood Institute are looking for 5,000 people who have or might have diseases that affect their heart, blood vessels
See all news about Li-Fraumeni syndrome

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Common questions about Li-Fraumeni syndrome

What is Li-Fraumeni syndrome?

Li-Fraumeni syndrome (LFS), also known as SBLA syndrome (sarcoma, breast, leukemia, and adrenal gland cancer syndrome), is a rare hereditary cancer predisposition disorder caused by germline pathogenic variants in the TP53 tumor suppressor gene located on chromosome 17p13.1. The TP53 gene encodes the p53 protein, often called the 'guardian of the genome,' which plays a critical role in regulating cell division, DNA repair, and programmed cell death (apoptosis). When this gene is dysfunctional, cells with damaged DNA can proliferate unchecked, dramatically increasing the risk of developing mult

How is Li-Fraumeni syndrome inherited?

Li-Fraumeni syndrome follows a autosomal dominant inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

Are there clinical trials for Li-Fraumeni syndrome?

Yes — 9 recruiting clinical trials are currently listed for Li-Fraumeni syndrome on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Li-Fraumeni syndrome?

16 specialists and care centers treating Li-Fraumeni syndrome are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.