UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060166 |
|---|---|
| Receipt number | R000068777 |
| Scientific Title | Features of duodenal lesions in patients with familial adenomatous polyposis: Multicenter retrospective cohort study |
| Date of disclosure of the study information | 2025/12/25 |
| Last modified on | 2025/12/22 16:55:20 |
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Basic information
Public title
Features of duodenal lesions in patients with familial adenomatous polyposis: Multicenter retrospective cohort study
Acronym
Features of duodenal lesions in patients with familial adenomatous polyposis: Multicenter retrospective cohort study
Scientific Title
Features of duodenal lesions in patients with familial adenomatous polyposis: Multicenter retrospective cohort study
Scientific Title:Acronym
Features of duodenal lesions in patients with familial adenomatous polyposis: Multicenter retrospective cohort study
Region
| Japan |
Condition
Condition
Familial adenomatous polyposis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To compare the time to progression of Spigelman stage between patients treated at IDP-performing institutions (IDP group) and those at institutions not performing IDP (non-IDP group).
Basic objectives2
Others
Basic objectives -Others
Association
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in time until progression of Spigelman stage between patients at IDP group and those at non-IDP group.
Key secondary outcomes
Incidence of duodenal cancer and duodenal surgery in IDP vs. non-IDP groups
Proportion of patients with stage IV Spigelman classification at 2 years after endoscopic treatment and at the final EGD
Comparison of longitudinal Spigelman stage changes between IDP and non-IDP groups
These secondary outcomes will be evaluated in a comprehensive and exploratory manner.
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
Patients who visited Hyogo Medical University Hospital or participating institutions between January 1, 2016 and December 31, 2023, were clinically diagnosed with familial adenomatous polyposis (FAP), and were found to have duodenal adenomas or duodenal carcinoma on esophagogastroduodenoscopy during the observation period.
Key exclusion criteria
(a) Fewer than two EGDs during observation
(b) Prior surgeries preventing duodenal observation (gastrectomy, pancreaticoduodenectomy, etc.)
(c) Current or past chemotherapy for non-duodenal malignancies
(d) Inflammatory bowel disease
(e) Opt-out request from the participant
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Shinzaki |
Organization
Hyogo Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6111
sh-shinzaki@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Okugawa |
Organization
Hyogo Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6111
Homepage URL
okugawat@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Hyogo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Board of Hyogo Medical University
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
Tel
0798-45-6066
rinri@hyo-med.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
兵庫医科大学病院（兵庫県）、大阪国際がんセンター（大阪府）、石川消化器内科（大阪府）、慶應義塾大学病院（東京都）、がん研究会有明病院（東京都）、国立がん研究センター中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 25 | 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
385
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
| 2024 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
NoneThis multicenter retrospective observational study investigates the association between endoscopic treatment strategies (institutions implementing intensive downstaging polypectomy versus those not implementing it) and disease progression, defined as progression of the Spigelman stage, in patients with familial adenomatous polyposis. Exploratory analyses will also assess associations between disease progression and patient-related factors (such as age, sex, and APC gene status) as well as lesion-related factors (including number of adenomas, maximum lesion size, and histological grade).
Management information
Registered date
| 2025 | Year | 12 | Month | 22 | Day |
Last modified on
| 2025 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068777
