UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045855 |
|---|---|
| Receipt number | R000052218 |
| Scientific Title | A multi-institutional prospective clinical trial to determine the feasibility of a cancer surveillance program and to explore new biomarkers for Li-Fraumeni Syndrome |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2025/05/19 21:22:09 |
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Basic information
Public title
A multi-institutional prospective clinical trial to determine the feasibility of a cancer surveillance program and to explore new biomarkers for Li-Fraumeni Syndrome
Acronym
A multi-institutional prospective clinical trial to determine the feasibility of a cancer surveillance program and to explore new biomarkers for Li-Fraumeni Syndrome
Scientific Title
A multi-institutional prospective clinical trial to determine the feasibility of a cancer surveillance program and to explore new biomarkers for Li-Fraumeni Syndrome
Scientific Title:Acronym
A multi-institutional prospective clinical trial to determine the feasibility of a cancer surveillance program and to explore new biomarkers for Li-Fraumeni Syndrome
Region
| Japan |
Condition
Condition
Li-Fraumeni Syndrome
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Breast surgery |
| Pediatrics | Orthopedics | Radiology |
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
to determine the feasibility of a cancer surveillance program for Li-Fraumeni Syndrome
Basic objectives2
Others
Basic objectives -Others
Efficacy of Liquid biopsy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
One-year continuity of the surveillance program
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
LFS Cancer Surveillance Program
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
| 39 | years-old | >= |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
30
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 4600001
TEL
052-951-1111
hiroyoshi.hattori@nnh.go.jp
Public contact
Name of contact person
| 1st name | Fumito |
| Middle name | |
| Last name | Yamazaki |
Organization
Keio University School of Medicine
Division name
Department of Pediatrics
Zip code
160-8582
Address
35 Shinano-Cho, Shinjyuku-ku, Tokyo
TEL
03-5363-3816
Homepage URL
fumyamaz@keio.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
| 2021 | Year | 10 | Month | 26 | 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
85
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 09 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052218
