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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022289
Receipt No. R000025589
Scientific Title Establishment of Diagnostic Method for Patients with Enterocolitis Related to Familial Mediterranean Fever Gene
Date of disclosure of the study information 2016/06/01
Last modified on 2021/05/21

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Basic information
Public title Establishment of Diagnostic Method for Patients with Enterocolitis Related to Familial Mediterranean Fever Gene
Acronym Diagnosis for MEFV gene-related enterocolitis
Scientific Title Establishment of Diagnostic Method for Patients with Enterocolitis Related to Familial Mediterranean Fever Gene
Scientific Title:Acronym Diagnosis for MEFV gene-related enterocolitis
Region
Japan

Condition
Condition inflammatory bowel disease (particularly, inflammatory bowel disease unclassified)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To establish diagnostic methods for patients with enterocolitis related to familial mediterranean fever gene
Basic objectives2 Others
Basic objectives -Others To make the diagnostic guidline for MEFV-gene related to enterocolitis by clinical characterstics (including clinical course, endoscopic features and histopathology)
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To elucidate clinical characteristics of patients with enterocolitis related to familial mediterranean fever gene
1)mutation site of MEFV gene
2)characteritics of clnical symptoms
3)endoscopic features
4)histopathologic features of intestinal lesions
5)microbiome characteristics
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients from whom we get informed consent.
Key exclusion criteria Any patients to be unsuitable for participating in this study judged by the investigator
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Nakase
Organization Sapporo Medical University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 060-8543
Address South 1 West 16, Chuo-ku, Sapporo, Japan
TEL 011-611-2111
Email hiropynakase@gmail.com

Public contact
Name of contact person
1st name Kohei
Middle name
Last name Wagatsuma
Organization Sapporo Medical University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 060-8543
Address South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan
TEL 011-611-2111
Homepage URL
Email k.wagatsuma@sapmed.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Health and Labour Sciences Research Grants
for research on intractable diseases from the Ministry of Health, Labour and
Welfare of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) The Uehara Memorial Foundation
Japan Agency for Medical Research and Development

IRB Contact (For public release)
Organization Clinical Research Section, Research Support Section, Secretariat, Sapporo Medical University
Address South 1 West 17, Chuo-ku, Sapporo, Japan
Tel 011-611-2111
Email ji-rskk@sapmed.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 札幌医科大学医学部 消化器内科学講座(北海道)、青山内科クリニック:胃大腸内視鏡/IBDセンター(兵庫県)、旭川医科大学病院 第三内科(消化器内科)(北海道)、いづろ今村病院 消化器内科(鹿児島県)、岩手医科大学附属病院 消化管内科(岩手県)、浦添総合病院 消化器病センター(沖縄県)、大阪医科大学 第二内科(大阪府)、大阪市立大学医学部附属病院 消化器内科(大阪府)、大阪大学医学部附属病院 消化器内科(大阪府)、関西医科大学香里病院 内科(大阪府)、北里大学医学部 消化器内科学(神奈川県)、北里大学北里研究所病院 炎症性腸疾患先進治療センター(東京都)、北野病院 脳神経内科(大阪府)、岐阜大学医学部附属病院 消化器内科(岐阜県)、九州大学病院 消化管内科(福岡県)、京都大学医学部附属病院 内視鏡部(京都府)、杏林大学医学部付属病院 消化器内科(東京都)、慶應義塾大学病院内視鏡センター(東京都)、神戸大学医学部附属病院 消化器内科(兵庫県)、国立成育医療研究センター 消化器内科(東京都)、埼玉医科大学病院 消化管内科(埼玉県)、佐賀大学附属病院 光学医療診療部(佐賀県)、札幌厚生病院 消化器内科IBDセンター(北海道)、滋賀医科大学医学部附属病院 消化器内科(滋賀県)、順天堂大学医学部附属順天堂医院 消化器内科(東京都)、製鉄記念八幡病院 消化器内科(福岡県)、筑波大学医学医療系 消化器内科(茨城県)、辻中病院柏の葉 消化器内科・IBDセンター(千葉県)、東京医科歯科大学 膠原病・リウマチ内科(東京都)、東京慈恵会医科大学附属病院 消化器・肝臓内科(東京都)、東邦大学医療センター佐倉病院 消化器内科学(千葉県)、東北労災病院 胃腸内科(宮城県)、戸畑共立病院 消化器病センター(福岡県)、富山県立中央病院 消化器内科(富山県)、富山大学附属病院 第三内科(消化器内科)(富山県)、土庫病院 外科・大腸肛門病センター(奈良県)、名古屋大学医学部附属病院 消化器内科(愛知県)、奈良県立医科大学 消化器・総合外科(奈良県)、新潟大学医歯学総合病院 光学医療診療部(新潟県)、日本大学病院 消化器内科(東京都)、兵庫医科大学病院 炎症性腸疾患内科(兵庫県)、弘前大学大学院医学研究科・消化器血液内科学講座(青森県)、福岡大学医学部 消化器内科(福岡県)、福岡大学筑紫病院 消化器内科(福岡県)、藤田医科大学病院 消化器内科学Ⅰ(愛知県)、防衛医科大学校病院 消化器内科(埼玉県)、松山赤十字病院 胃腸センター(愛媛県)、三重大学病院 消化管外科(三重県)、横浜市立市民病院 炎症性腸疾患センター(神奈川県)、横浜市立大学附属市民総合医療センター 炎症性腸疾患センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 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
Results Approximately 300 patients have already been enrolled. Now, we analyzed the data including patients' information and the result of MEFV gene mutation.
Results date posted
2021 Year 05 Month 19 Day
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
2016 Year 06 Month 01 Day
Date of IRB
2016 Year 07 Month 14 Day
Anticipated trial start date
2016 Year 07 Month 14 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We have already performed analysis of MEFV gene mutation in Japanese patients with ulcerative colitis and Crohn's disease

Management information
Registered date
2016 Year 05 Month 12 Day
Last modified on
2021 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025589

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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