UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050963 |
|---|---|
| Receipt number | R000058090 |
| Scientific Title | Efficacy of biomarkers for predicting relapse in patients with ulcerative colitis with clinical remission: A single-center prospective study |
| Date of disclosure of the study information | 2023/05/20 |
| Last modified on | 2025/02/27 17:41:43 |
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Basic information
Public title
Efficacy of biomarkers for predicting relapse in patients with ulcerative colitis with clinical remission: A single-center prospective study
Acronym
Efficacy of biomarkers for predicting relapse in patients with ulcerative colitis with clinical remission: A single-center prospective study
Scientific Title
Efficacy of biomarkers for predicting relapse in patients with ulcerative colitis with clinical remission: A single-center prospective study
Scientific Title:Acronym
Efficacy of biomarkers for predicting relapse in patients with ulcerative colitis with clinical remission: A single-center prospective study
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of biomarkers for predicting relapse in patients with ulcerative colitis with clinical remission.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity and specificity of biomarkers for clinical relapse in patients with ulcerative colitis with clinical remission.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who met the criteria for ulcerative colitis
2) Patients over 18 years old
3) Patients with clinical remission (Partial Mayo score under 2) over 3 months
4) In combination therapy, patients on a constant dose before this study participation as follows:
(a)5-aminosalicylic acid over 4 weeks
(b)immunomodulators over 4 weeks
(c)biologics over 8 weeks
5) Patients who have contents for this study
Key exclusion criteria
1) Patients who are hospitalized
2) Patients with colostomy
3) Patients who are pregnant or may become pregnant
4) Patients who smoke
5) Patients with other inflammatory diseases
6) Patients receiving the following treatments within 4 weeks
(a)NSAIDs
(b)Aspirin
(c)Budesonide rectal foam and enemas
(d)Corticosteroids
(e)Cytapheresis
7) Patients with malignant tumors (except after resection or remission)
8) Patients judged to be inappropriate for inclusion in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naohiro |
| Middle name | |
| Last name | Kato |
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name
Department of Gastroenterology
Zip code
737-0023
Address
3-1, Aoyama-cho, Kure, Hiroshima
TEL
0823-22-3111
kato.naohiro.zy@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Naohiro |
| Middle name | |
| Last name | Kato |
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name
Department of Gastroenterology
Zip code
737-0023
Address
3-1, Aoyama-cho, Kure, Hiroshima
TEL
0823-22-3111
Homepage URL
kato.naohiro.zy@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Address
3-1, Aoyama-cho, Kure, Hiroshima
Tel
0823-22-3111
yano.keigo.yf@mail.hosp.go.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
| 2023 | Year | 05 | Month | 20 | 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
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There are no plans for monitoring/auditing because of observational study.
Management information
Registered date
| 2023 | Year | 04 | Month | 29 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058090
