UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035490 |
|---|---|
| Receipt number | R000040417 |
| Scientific Title | Diagnosis, treatment and prognosis of the neoplastic lesions in patients with inflammatory bowel disease: A multicenter study |
| Date of disclosure of the study information | 2019/01/10 |
| Last modified on | 2022/01/10 13:01:12 |
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Basic information
Public title
Diagnosis, treatment and prognosis of the neoplastic lesions in patients with inflammatory bowel disease: A multicenter study
Acronym
Diagnosis, treatment and prognosis of the neoplastic lesions in patients with inflammatory bowel disease: A multicenter study
Scientific Title
Diagnosis, treatment and prognosis of the neoplastic lesions in patients with inflammatory bowel disease: A multicenter study
Scientific Title:Acronym
Diagnosis, treatment and prognosis of the neoplastic lesions in patients with inflammatory bowel disease: A multicenter study
Region
| Japan |
Condition
Condition
Ulcerative colitis, Crohn's disease
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinicopathological features and prognostic factors in IBD patients with neoplasia. We also evaluate the appropriate disease management strategy in consideration of the cancerization risk.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence and breakdown of IBD-associated neoplasia or malignancy in other organs
Key secondary outcomes
1)Factors associated with a poor prognosis in patients with IBD-associated neoplasia or malignancy in other organs
2)Diagnostic value of image-enhanced endoscopy in patients with IBD-associated neoplasia
3)The effect of immunomodulatory or biologics on the risk of IBD-associated neoplasia or malignancy in other organs
4)Outcome of the endoscopic or surgical treatment for IBD-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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)IBD patients with previous consultation from Jan. 1st, 2008 to Dec. 31st, 2020
2) IBD patients whose IBD-associated neoplasia or malignancy in other organs which had been confirmed by endoscopy, CT, histological analysis, etc.
Key exclusion criteria
1)Patients without adequate confirmation of neoplasms.
2)Patients whom investigators considered inappropriate to participate in this study.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Takanari |
| Middle name | |
| Last name | Kitazono |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
812-8582
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-5261
kitazono@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Fujioka |
Organization
Kyushu University Hospital
Division name
Department of Endoscopic Diagnositics and Therapeutics
Zip code
812-8582
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-5261
Homepage URL
fujioka.shin.279@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Hospital
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
Tel
092-642-5774
ijkseimei@jimu.kyushu-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
九州大学病院（福岡県）、福岡大学筑紫病院（福岡県）、久留米大学病院（福岡県）、福岡大学病院（福岡県）、芦屋中央病院（福岡県）、北九州市立医療センター（福岡県）、産業医科大学病院（福岡県）、製鉄記念八幡病院（福岡県）、戸畑共立病院（福岡県）、小倉医療センター（福岡県）、佐賀大学医学部附属病院（佐賀県）、嬉野医療センター（佐賀県）、長崎大学病院（長崎県）、長崎医療センター（長崎県）、春回会井上病院（長崎県）、大分大学医学部附属病院（大分県）、石田消化器IBDクリニック（大分県）、大分赤十字病院（大分県）、熊本大学医学部附属病院（熊本県）、鹿児島大学病院（鹿児島県）、いづろ今村病院（鹿児島県）、潤愛会鮫島病院（鹿児島県）、宮崎大学医学部附属病院（宮崎県）、潤和会記念病院（宮崎県）、琉球大学医学部附属病院（沖縄県）、浦添総合病院（沖縄県）、那覇市立病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 10 | 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
| 2018 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
n/a
Management information
Registered date
| 2019 | Year | 01 | Month | 08 | Day |
Last modified on
| 2022 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040417
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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