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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035490
Receipt No. 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 2019/01/08

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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, 2017
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
Middle name
Last name Takanari Kitazono
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Medicine and Clinical Science
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL 092-642-5261
Email kitazono@intmed2.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin Fujioka
Organization Kyushu University Hospital
Division name Department of Endoscopic Diagnositics and Therapeutics
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL 092-642-5261
Homepage URL
Email sfujioka@intmed2.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2018 Year 12 Month 28 Day
Last follow-up date
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
2019 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040417

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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