UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049021 |
|---|---|
| Receipt number | R000049055 |
| Scientific Title | Development of Ulcerative Colitis-Associated Colorectal Cancers -A Prospective Case Registry Study |
| Date of disclosure of the study information | 2022/09/26 |
| Last modified on | 2024/03/28 11:24:32 |
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Basic information
Public title
Development of Ulcerative Colitis-Associated Colorectal Cancers -A Prospective Case Registry Study
Acronym
Surveillance for UC-Associated Colorectal Cancers
Scientific Title
Development of Ulcerative Colitis-Associated Colorectal Cancers -A Prospective Case Registry Study
Scientific Title:Acronym
Surveillance for UC-Associated Colorectal Cancers
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence of ulcerative colitis-associated colorectal cancer in Japan
Basic objectives2
Others
Basic objectives -Others
To establish an appropriate surveillance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative incidence of ulcerative colitis-associated colorectal cancer
Key secondary outcomes
(1)Clinical background of colorectal cancer patients
(2)Pathology of colorectal cancer
(3)A retrospective study of endoscopic findings prior to the detection of colorectal cancer
(4)Cumulative incidence of dysplasia
(5)Cumulative incidence of sporadic colorectal tumors
(6)Cumulative incidence of multiple cancers
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with UC
More than 8 years since onset
At least 20 years old at the time of registration
ECOG-performance Status is 0 or 1
Key exclusion criteria
History of colorectal cancer
Previous colorectal resection
Serious underlying disease
Difficulty in endoscopic observation
Difficulty in obtaining written consent
The physician in charge judges it inappropriate
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Hisabe |
Organization
Fukuoka University Chikushi Hospital
Division name
Gastroenterology
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikiushino, Fukuoka
TEL
092-921-1011
hisabe@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigeyosi |
| Middle name | |
| Last name | Yasukawa |
Organization
Fukuoka University Chikushi Hospital
Division name
Gastroenterology
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikiushino, Fukuoka
TEL
092-921-1011
Homepage URL
lahakatanomori@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
No
Name of secondary funder(s)
No
IRB Contact (For public release)
Organization
Fukuoka University Medical Ethics Committee
Address
7-45-1 Jyonanku Nanakuma, Fukuoka, Fukuoka
Tel
092-801-1011
fumed-ethics@fukuoka-u.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | 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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2033 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cumulative incidence of colon cancer
Management information
Registered date
| 2022 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049055
