UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062487 |
|---|---|
| Receipt number | R000071511 |
| Scientific Title | A Retrospective Study of Pancreatic Lesions in Patients with Peutz-Jeghers Syndrome |
| Date of disclosure of the study information | 2026/08/15 |
| Last modified on | 2026/08/05 22:33:22 |
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Basic information
Public title
A Retrospective Study of Pancreatic Lesions in Patients with Peutz-Jeghers Syndrome
Acronym
A Retrospective Study of Pancreatic Lesions in Patients with Peutz-Jeghers Syndrom
Scientific Title
A Retrospective Study of Pancreatic Lesions in Patients with Peutz-Jeghers Syndrome
Scientific Title:Acronym
A Retrospective Study of Pancreatic Lesions in Patients with Peutz-Jeghers Syndrome
Region
| Japan |
Condition
Condition
Peutz-Jeghers syndrome
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study will retrospectively collect clinical information and data on patients with Peutz-Jeghers syndrome who have received medical care at our institution. Patient characteristics, the presence or absence of concomitant conditions, including malignant neoplasms, and clinical courses will be investigated.
With regard to pancreatic lesions, data will be collected irrespective of whether the lesions are benign or malignant. The timing of lesion development or diagnosis, surveillance status, prognosis, treatment history, and other aspects of the clinical course will be assessed, together with laboratory, imaging, and histopathological findings. The aim of this study is to characterize the clinical features of pancreatic lesions in patients with Peutz-Jeghers syndrome based on data obtained in real-world clinical practice.
Basic objectives2
Others
Basic objectives -Others
Cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical findings related to pancreatic lesions, including the diagnosis and date of diagnosis of pancreatic lesions; family history of pancreatic cancer; results of laboratory tests related to pancreatic disease; findings from ultrasonographic, radiological, and endoscopic examinations; histopathological findings; surveillance intervals and modalities for pancreatic lesions; longitudinal changes in clinical and imaging findings; and, where treatment was administered, treatment details and clinical outcomes.
Key secondary outcomes
Age; sex; family history of Peutz-Jeghers syndrome; date of diagnosis of Peutz-Jeghers syndrome; duration of follow-up at our institution; serum carbohydrate antigen 19-9 levels; history of malignant neoplasms, irrespective of the organ of origin; age at diagnosis of each malignant neoplasm; and treatments administered for malignant neoplasms.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Peutz-Jeghers syndrome who received medical care at Jichi Medical University Hospital between May 1, 2006, and June 18, 2026.
Key exclusion criteria
Patients who have declined participation in this study.
Target sample size
94
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Sakurai |
Organization
Jichi Medical University
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan
TEL
0285-58-7348
y.sakurai@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Sakurai |
Organization
Jichi Medical University
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan
TEL
0285-58-7348
Homepage URL
y.sakurai@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Sakurai Yusuke
Funding Source
Organization
Jichi Medical University
Division of Gastroenterology, Department of Internal Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical Investigation Jichi MEdical University Hospital
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan
Tel
0285-58-8933
rinri@jichi.ac.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
自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 15 | 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
94
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
| 2026 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical information relevant to the study will be retrospectively collected using the case report form (data sheet) provided in the Appendix for patients with Peutz-Jeghers syndrome who received medical care at Jichi Medical University Hospital between May 1, 2006, and the date of approval of this clinical research study.
Information regarding the conduct of this study will be posted on the website of the Center for Clinical Investigation, Jichi Medical University Hospital. For patients who underwent testing for STK11 genetic variants as part of clinical care and whose results are documented in the medical records, the results will also be collected as part of the clinical information. Clinicopathological information related to Peutz-Jeghers syndrome will be collected irrespective of whether other affected individuals are present within the patient's family.
When surgery or chemotherapy for pancreatic lesions has been performed at another institution, information regarding the treatment course and examination results, as well as histopathological slides, will be obtained from the relevant institution and evaluated. The materials provided will not include unstained slides.
For patients who are no longer receiving care at our hospital and whose outcomes are unknown, every reasonable effort will be made to obtain follow-up information by telephone or by contacting the medical institutions currently or previously involved in their care.
The role of the other institutions will be limited to the provision of existing specimens and information. They will not otherwise participate in the conduct of the study, including the statistical analysis.
Management information
Registered date
| 2026 | Year | 08 | Month | 05 | Day |
Last modified on
| 2026 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071511
