UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058379 |
|---|---|
| Receipt number | R000066746 |
| Scientific Title | Genetic analysis of ulcerative colitis-associated colorectal tumors and its relation with genetic polymorphisms |
| Date of disclosure of the study information | 2025/07/06 |
| Last modified on | 2025/07/06 20:13:26 |
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Basic information
Public title
Genetic analysis of ulcerative colitis-associated colorectal tumors and its relation with genetic polymorphisms
Acronym
Genetic analysis of UCAN
Scientific Title
Genetic analysis of ulcerative colitis-associated colorectal tumors and its relation with genetic polymorphisms
Scientific Title:Acronym
Genetic analysis of UCAN
Region
| Japan |
Condition
Condition
ulcerative colitis-associated neoplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine the association between tumor-related TP53 genetic abnormalities and genetic polymorphisms in ulcerative colitis-associated neoplasia
Basic objectives2
Others
Basic objectives -Others
To determine the association between tumor-related genetic abnormalities other than TP53 and genetic polymorphisms in ulcerative colitis-associated neoplasia
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Association between tumor-related TP53 genetic abnormalities and genetic polymorphisms in ulcerative colitis-associated neoplasia
Key secondary outcomes
To determine the association between tumor-related genetic abnormalities other than TP53 and genetic polymorphisms in ulcerative colitis-associated neoplasia
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
ulcerative colitis-associated neoplasia and sporadic colorectal tumors diagnosed and treated at Fujita Health University Hospitals
Key exclusion criteria
None
Target sample size
231
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Ohmiya |
Organization
Fujita Health University Hospital
Division name
Department of Advanced Endoscopy
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562939240
nohmiya@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ohmiya |
Organization
Fujita Health University Hospital
Division name
Department of Advanced Endoscopy
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562939240
Homepage URL
nohmiya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Naoki Ohmiya
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Fujita University School of Medicine
Address
1-98 Dengakugakubo Kutsu kake-cho, Toyoake, Aichi
Tel
0562-93-2139
chiken@fujita-hu.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
藤田医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 06 | 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
Genetic analysis is being performed.
Results date posted
| 2025 | Year | 07 | Month | 06 | Day |
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
| 2025 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 08 | Month | 31 | Day |
Other
Other related information
Colorectal tumor-associated genetic abnormalities, genetic polymorphisms
Management information
Registered date
| 2025 | Year | 07 | Month | 06 | Day |
Last modified on
| 2025 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066746
