UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062667 |
|---|---|
| Receipt number | R000071739 |
| Scientific Title | Multicenter Collaborative Registry Study of Lynch Syndrome |
| Date of disclosure of the study information | 2026/08/24 |
| Last modified on | 2026/08/24 20:58:36 |
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Basic information
Public title
Multicenter Collaborative Registry Study of Lynch Syndrome
Acronym
JSHT LS Registry
Scientific Title
Multicenter Collaborative Registry Study of Lynch Syndrome
Scientific Title:Acronym
JSHT LS Registry
Region
| Japan |
Condition
Condition
Lynch syndrome
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Hematology and clinical oncology | Nephrology | Surgery in general |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Breast surgery |
| Obstetrics and Gynecology | Pediatrics | Dermatology |
| Urology | Neurosurgery | Operative medicine |
| Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to clarify the malignant tumor profile, cancer risk, treatment course, recurrence, and prognosis in Lynch syndrome, and to establish appropriate surveillance.
Basic objectives2
Others
Basic objectives -Others
the malignant tumor profile, cancer risk, treatment course, recurrence, and prognosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of Lynch syndrome-associated tumors by causative gene
Key secondary outcomes
Number of death events (proportion)
Cumulative mortality rate by causative gene
Distribution of causes of death
Standardized mortality ratio
Exploration of factors associated with lesion incidence using multivariate analysis and machine learning
Development of a prognostic prediction model using machine learning
Treatment rate (chemoprevention, endoscopic treatment, surgical treatment, etc.)
Surveillance methods
Age at surveillance initiation
Surveillance interval
Marriage rate
Pregnancy rate (or partner's pregnancy, for male patients)
Childbirth rate (or partner's childbirth, for male patients)
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals diagnosed with Lynch syndrome by genetic testing 1)
or individuals judged to be genetically appropriate as having Lynch syndrome 2)
1) Carriers of a pathogenic variant in a mismatch repair gene that, as of the time of registration, has been judged pathogenic or likely pathogenic by any public database (excluding in silico analysis) or by the ACMG/AMP guidelines
2) Cases judged to be appropriate as having Lynch syndrome
- When a second-degree relative has been diagnosed with Lynch syndrome based on the same variant, the first-degree relatives of both individuals (e.g., the father, when the individual and the paternal grandfather have been diagnosed)
2. Individuals aged 16 years or older at the time of consent
3. Individuals who have undergone surveillance for Lynch syndrome at least once at a collaborating institution 3)
3) "Surveillance" refers to examinations and tests performed to check for the presence or absence of tumor development, and does not include consultations, genetic counseling, genetic testing, etc.
4. For the "prospective observational study," individuals who, after receiving a full explanation regarding participation in this study and gaining full understanding, provided written consent of their own free will
Note: Participation in this study does not depend on the timing of Lynch syndrome diagnosis, participation in other clinical studies, or the presence or absence of tumor development.
Note: Individuals whose tumor tissue showed microsatellite instability or loss of mismatch repair protein expression (in the case of colorectal cancer, this also includes BRAF wild-type cases), as well as first-degree relatives of individuals with Lynch syndrome who have developed a Lynch syndrome-associated tumor, are excluded from eligibility.
Key exclusion criteria
1. Individuals whose genetic testing identified a variant classified as a Variant of Unknown Significance (VUS)
2. For the "retrospective observational study," individuals who declined to participate in the study
3. Other individuals judged by the principal investigator to be inappropriate as study subjects
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tatsuro |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Department of Clinical Genetics
Zip code
113-8677
Address
3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL
03-3823-2101
tatsuro@yamaguchi.email.ne.jp
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Department of Clinical Genetics
Zip code
113-8677
Address
3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL
03-3823-2101
Homepage URL
tatsuro@yamaguchi.email.ne.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department
Personal name
Tatsuro Yamaguchi
Funding Source
Organization
The Japanese Society for Hereditary Tumors
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Hospital Organization
Address
2-8-1, Nishi-Shinjuku, Shinjuku-ku, Tokyo
Tel
03-5320-5812
tatsuro@yamaguchi.email.ne.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
がん・感染症センター都立駒込病院（東京都）
東北医科薬科大学 腫瘍内科学教室（宮城県）
埼玉県立がんセンター 遺伝科（埼玉県）
国立がん研究センター東病院 遺伝子診療部門（千葉県）
東京大学医学部附属病院 ゲノム診療部（東京都）
がん研有明病院（東京都）
富山県立中央病院 皮膚科・遺伝診療科（富山県）
三重大学医学部附属病院（三重県）
京都大学医学部附属病院 腫瘍内科（京都府）
京都府立医科大学 分子標的予防医学（京都府）
医療法人いちょう会 石川消化器内科 消化器内科（大阪府）
岡山大学病院 臨床遺伝子診療科（岡山県）
広島大学病院 遺伝子診療科（広島県）
広島大学病院 消化器内科（広島県）
岩国医療センター 外科（山口県）
産業医科大学 第１外科（福岡県）
九州大学病院 消化管外科/臨床遺伝医療部（福岡県）
埼玉医科大学総合医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2036 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
- retrospective observational study
- prospective observational study
Management information
Registered date
| 2026 | Year | 08 | Month | 24 | Day |
Last modified on
| 2026 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071739
