A prospective observational study to evaluate the efficacy of a Cancer Surveillance for children and adolescent/young adults with Li-Fraumeni syndrome

A prospective observational study to evaluate the efficacy of a Cancer Surveillance Programme based on whole-body MRI imaging for children and adolescent/young adults with Li-Fraumeni syndrome - A prospective observational study to evaluate the efficacy of surveillance based on whole-body MRI in children and AYA individuals with Li-Fraumeni syndrome

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058466

Enrollment

Registered

2025-07-22

Start date

2025-07-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Li-Fraumeni syndrome

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Individuals who meet all of the following criteria will be eligible for the cancer surveillance programme. (1) Positive TP53 genetic test (in this study or OVUS test in LFS20)or classical criteria a) matching cases. (2) Age 39 or younger at the time of consent (LFS20 participants over the age of 39 are included) (3) ECOG Performance Status(ECOG PS)of 0-2. (4) Individuals who have not developed cancer, or who have developed cancer but have maintained remission for more than one year after completion of treatment. Note: Treatment refers to surgery, radiation therapy, chemotherapy(anticancer drugs), and molecular targeted therapy. (Hormone therapy is permissible during this period) (5) Individuals who have undergone genetic counseling and consented to TP53 genetic testing. (6) Individuals who have obtained written consent.

Exclusion criteria

Exclusion criteria: Individuals who fit any of the following categories will be excluded from the cancer surveillance programme. (1) Women who are pregnant or suspected of being pregnant. (2) Individuals for whom MRI scanning is contraindicated. (3) Individuals who require sedation for MRI scanning. (4) Individuals who are deemed unsuitable for participation in this study by the principal investigator or researchers.

Design outcomes

Primary

Measure	Time frame
Detection of early-stage cancer by whole-body MRI during a two-year observation period Detection of cancer through cancer surveillance programme during a two-year observation period	—

Secondary

Measure	Time frame
Early detection of cancer by whole-body MRI in the second year Early detection of cancer by whole-body MRI in the first year Results of medical examination, blood tests, abdominal and breast ultrasound, segmental whole-body MRI, and colonoscopy Number of cases that require further examination, number of cases of actual cancer Results of interviews Adverse events in participants of the surveillance programm	—

Measure

Time frame

Early detection of cancer by whole-body MRI in the second year Early detection of cancer by whole-body MRI in the first year Results of medical examination, blood tests, abdominal and breast ultrasound, segmental whole-body MRI, and colonoscopy Number of cases that require further examination, number of cases of actual cancer Results of interviews Adverse events in participants of the surveillance programm

—

Countries

Japan

Contacts

Public ContactFumito Yamasaki

National Cancer Center Hospital Department of Genetic Medicine

fuyamaz2@ncc.go.jp03-3542-2511

Outcome results