UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052403 |
|---|---|
| Receipt number | R000059822 |
| Scientific Title | Registry for elderly inflammatory bowel disease patients |
| Date of disclosure of the study information | 2023/10/04 |
| Last modified on | 2024/04/04 15:28:46 |
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Basic information
Public title
Registry for elderly inflammatory bowel disease patients
Acronym
Elderly IBD Registry
Scientific Title
Registry for elderly inflammatory bowel disease patients
Scientific Title:Acronym
Elderly IBD Registry
Region
| Japan |
Condition
Condition
inflammatory bowel disease (IBD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By collecting clinical information on elderly patients with inflammatory bowel disease (IBD) and examining evaluation items on a continuous and long-term basis, we aim to clarify the challenges of IBD treatment in an aging society and find solutions to them.
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Name and contact information
2) Date of birth, gender
3) Diagnosis name
4) Diagnosis status
5) Certification as a designated intractable disease patient
6) Month and year of onset
7) Date of diagnosis
8) Height
9) Weight
10) IBD family history
11) Smoking history
12) Drinking history
13) Scope of disease
14) Disease type (Crohn's disease only)
15) Concomitant diseases
16) Extraintestinal complications [arthralgia, erythema nodosum, episcleritis, pyoderma gangrenosum, uveitis, peripheral
spondyloarthritis, axial spondyloarthritis, primary sclerosing cholangitis, others] (including past cases)
17) History of hospitalization due to IBD
18) Treatment history
19) Cohabitant
20) Nursing care insurance certification
21) Frailty (basic checklist)
22) Oral frailty (8 items)
23) History of malignant tumor
24) History of falls/fractures
25) Concomitant drugs
26) Polypharmacy
27) History of thrombosis
28) Owning a smartphone
29) Current number of teeth
30) Medical institution name
31) Clinical department,
32) Health status (EQ-5D-5L),
33) Outcome
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 75 years or older who have been diagnosed with IBD according to the diagnostic criteria of the Intractable Disease Research Group supervised by the Ministry of Health, Labor and Welfare.
2) Patients who have given written consent to participate in the study
Key exclusion criteria
1) Patients who are judged to be inappropriate as subjects by the researcher's judgment
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Tadakazu |
| Middle name | |
| Last name | Hisamatsu |
Organization
Kyorin University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
181-8611
Address
6-20-2 SHinkawa, Mitaka
TEL
0422-47-5511
thisamatsu@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Kobayashi |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
5-9-1 Shirokane
TEL
0357916487
Homepage URL
drkobataku@gmail.com
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2023 | Year | 10 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registry
Management information
Registered date
| 2023 | Year | 10 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059822
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
