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A multi-institutional prospective clinical trial to determine the feasibility of a cancer surveillance program and to explore new biomarkers for Li-Fraumeni Syndrome

A multi-institutional prospective clinical trial to determine the feasibility of a cancer surveillance program and to explore new biomarkers for Li-Fraumeni Syndrome - A multi-institutional prospective clinical trial to determine the feasibility of a cancer surveillance program and to explore new biomarkers for Li-Fraumeni Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045855
Enrollment
30
Registered
2021-10-26
Start date
2021-10-29
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

LFS Cancer Surveillance Program

Sponsors

Japan Children's Cancer Group,(JCCG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Following (1) through (6) . (1) Person who has diagnosed, suspected with Li-Fraumeni syndrome. A close relative of a person having TP53 pathogenic variant. (2) Age 39 years or younger (3) ECOG Performance Status (ECOG PS) of 0 to 2 (4) Person who have not yet developed cancer, or those who have already developed cancer but have been in remission for at least 1 year after completion of treatment. Treatment refers to surgical therapy, radiation therapy, chemotherapy (anti-cancer drugs), and molecular targeted therapy. (Hormone therapy is acceptable.) (5) Person who has received genetic counseling and consents to undergo TP53 genetic testing. (6) Person who have obtained written consent.

Exclusion criteria

Exclusion criteria: (1) Women who are pregnant or may become be pregnant. (2) Person with contraindications to MRI imaging (3) Person who require sedation for MRI imaging. (4) Those who are judged by the principal investigator or researcher to be inappropriate to participate in the research.

Design outcomes

Primary

MeasureTime frame
One-year continuity of the surveillance program

Secondary

MeasureTime frame
Efficacy of Each examination in the Surveillance Program Necessity of the Cancer Surveillance Program Efficacy of the Cancer Surveillance Program Benefits and Disadvantages of the Surveillance as Perceived by Study Participants Problems in implementing the cancer surveillance programs and how to address them Assessing the safety of the Cancer surveillance

Countries

Japan

Contacts

Public ContactFumito Yamazaki

Keio University School of Medicine Department of Pediatrics

fumyamaz@keio.jp03-5363-3816

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026