UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058466 |
|---|---|
| Receipt number | R000066790 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2025/07/22 |
| Last modified on | 2025/07/14 13:01:40 |
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Basic information
Public title
A prospective observational study to evaluate the efficacy of a Cancer Surveillance for children and adolescent/young adults with Li-Fraumeni syndrome
Acronym
Surveillance study of Li-Fraumeni syndrome in children and the AYA generation
Scientific Title
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
Scientific Title:Acronym
A prospective observational study to evaluate the efficacy of surveillance based on whole-body MRI in children and AYA individuals with Li-Fraumeni syndrome
Region
| Japan |
Condition
Condition
Li-Fraumeni syndrome
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Pediatrics |
| Orthopedics | Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The efficacy of cancer surveillance programme is evaluated by assessing both the detection of early-stage cancer through whole-body MRI and the detection of cancer through cancer surveillance programme.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Hattori |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Clinical Genetics
Zip code
460-0001
Address
4-1-1 Sannomaru, Naka-ku, Nagoya
TEL
052-951-1111
hiroyoshi.hattori@nnh.go.jp
Public contact
Name of contact person
| 1st name | Fumito |
| Middle name | |
| Last name | Yamasaki |
Organization
National Cancer Center Hospital
Division name
Department of Genetic Medicine
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
fuyamaz2@ncc.go.jp
Sponsor or person
Institute
Japan Children's Cancer Group,(JCCG)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Nagoya Medical Center, Institutional Revew Boad
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 4600001
Tel
052-951-1111
311-rec@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The current study is a cancer surveillance clinical study targeting children and adolescents with Li-Fraumeni syndrome (LFS). A cancer surveillance programme consisting of regular check-ups three times a year, including physical examinations, blood tests, and imaging tests centred on segmented whole-body MRI, will be implemented. The stage of the cancer detected and the circumstances of its discovery will be investigated to evaluate whether cancer surveillance contributes to the early diagnosis of LFS cancer.
Management information
Registered date
| 2025 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066790
