UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054487 |
|---|---|
| Receipt number | R000062239 |
| Scientific Title | Epidemiology of primary sclerosing cholangitis among patients with inflammatory bowel disease in Asian countries: An international multicenter retrospective study |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/05/26 17:10:06 |
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Basic information
Public title
Epidemiology of primary sclerosing cholangitis among patients with inflammatory bowel disease in Asian countries: An international multicenter retrospective study
Acronym
PSC-IBD in Asia
Scientific Title
Epidemiology of primary sclerosing cholangitis among patients with inflammatory bowel disease in Asian countries: An international multicenter retrospective study
Scientific Title:Acronym
PSC-IBD in Asia
Region
| Japan | Asia(except Japan) |
Condition
Condition
Inflammatory Bowel Disease (IBD), Primary Sclerosing Cholangitis (PSC)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Most of investigations regarding PSC-IBD have been conducted in Western countries and there are still few studies assessing clinical characteristics and outcomes of Asian patients with PSC-IBD. The main purpose of this retrospective multicenter study is to understand the clinical characteristics and outcomes of PSC-IBD patients in Asian countries including Japan, South Korea, China, Taiwan, India, Hong Kong, Singapore, Malaysia, Saudi Arabia, and Iran.
Basic objectives2
Others
Basic objectives -Others
Epidemiological survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of PSC among Asian patients with IBD
Key secondary outcomes
The risks of hospitalization, surgery (total colectomy and liver transplantation), and colorectal cancer in PSC-IBD will be assessed. We also evaluate endoscopic characteristics (e.g. disease locations and endoscopic severity) as well as other imaging, pathological, and biochemical findings related to intestinal and/or biliary diseases in PSC-IBD patients.
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
16 years of age and more than 16 yeas of age
Diagnosis of IBD (Ulcerative colitis or Crohn's disease) confirmed until the end date of this study
Diagnosis of PSC confirmed until the end date of this study
Key exclusion criteria
Patients who have expressed their unwillingness to participate
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Akiyama |
Organization
Institute of Medicine, University of Tsukuba
Division name
Department of Gastroenterology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan
TEL
029-853-3218
akiyama@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Akiyama |
Organization
Institute of Medicine, University of Tsukuba
Division name
Department of Gastroenterology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan
TEL
029-853-3218
Homepage URL
akiyama@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
None
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
Tsukuba Clinical Research & Development Organization
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, 305-8576, Japan
Tel
029-853-3914
t-credo.adm@un.tsukuba.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
Kansai Medical University (Japan)
Kyorin University School of Medicine (Japan)
Hyogo Medical University (Japan)
Keio University School of Medicine (Japan)
Saitama Medical University (Japan)
Juntendo University (Japan)
The University of Tokyo (Japan)
Toho University Sakura Medical Center (Japan)
University of Ulsan College of Medicine, Asan Medical Center (Korea)
Yeungnam University College of Medicine (Korea)
Ewha Womans University, Seoul hospital (Korea)
Chonnam National University Hospital (Korea)
Severance Hospital, Yonsei University College of Medicine (Korea)
Kyung Hee University School of Medicine (Korea)
Hanyang University Guri Hospital (Korea)
Rui Jin Hospital, affiliate to Shanghai Jiao Tong University, School of Medicine (China)
Sichuan University, West China Hospital (China)
Xijing Hospital IBD Center (China)
National Taiwan University (Taiwan)
National Taiwan University Hospital (Taiwan)
Changhua Christian Hospital (Taiwan)
Singapore General Hospital (Singapore)
Tan Tock Seng Hospital (Singapore)
University of Malaya (Malaysia)
Chinese University of Hong Kong (Hong Kong)
Pamela Youde Nethersole Eastern Hospital (Hong Kong)
Tuen Mun Hospital (Hong Kong)
DAYANAND MEDICAL COLLEGE AND HOSPITAL (India)
SMS Super Speciality Hospital (India)
All India Institute of Medical Sciences (India)
Medanta Hospital , Gurgaon (India)
P D HINDUJA HOSPITAL, Mumbai (India)
King Saud University (Saudi Arabia)
Shiraz Gastroenterology and Hepatology Clinic (Iran)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 01 | 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
300
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
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients aged 16 years and older with a confirmed diagnosis of IBD (Ulcerative colitis (UC) or Crohn's disease (CD)) or PSC at participating institutions (patients must have been diagnosed by 1 April 2028, the study end date). data will be collected retrospectively and the following medical data will be evaluated:
1. Date of birth,
2. Diagnosis of IBD and PSC and age of each disease onset
3. Gender
4. Race
5. Smoking history
6. Body Mass Index (BMI)
7. Family history of IBD
8. Past medical history
9. Disease extent of IBD based on Montreal classification
10. IBD medication use: biologics or small molecule therapies (e.g. anti-tumor necrosis factor, anti-integrin, anti-interleukin (IL)12/23 agents, Janus kinase inhibitors), systemic steroids, granulocyte and monocyte apheresis, and others.
11. Routine laboratory data such as liver function tests and inflammation markers (e.g. fecal calprotectin and C-reactive protein)
12. Imaging studies (e.g. magnetic resonance cholangiopancreatography and endoscopic retrograde cholangiopancreatography) and biopsy results (if available)
13. Clinical disease activity of IBD (Harvey-Bradshaw Index for CD, Simple Clinical Colitis Activity Index or partial Mayo score for UC)
14. Endoscopic disease activity of IBD (Mayo endoscopic subscore, Ulcerative colitis endoscopic index of severity, Simple Endoscopic Score for Crohn's disease, or modified endoscopic reports) and endoscopic phenotypes (e.g. rectal scaring, right-sided colitis, and backwash ileitis)
15. Extraintestinal manifestations other than PSC (e.g. arthritis, uveitis, pyoderma gangrenosum, erythema nodosum, aphthous stomatitis, ankylosing spondylitis, psoriasis)
16. Complications including hospitalizations, cancers (e.g. colorectal cancer, small intestinal cancer, and biliary tract cancer), surgeries (e.g. total colectomy, small bowel resection, and liver transplantation), infections, and mortality
Management information
Registered date
| 2024 | Year | 05 | Month | 26 | Day |
Last modified on
| 2024 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062239
