UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055869 |
|---|---|
| Receipt number | R000063848 |
| Scientific Title | Treatment response and transition of anti integrin alpha v beta 6 antibody titers in patients of ulcerative colitis that have newly started treatment |
| Date of disclosure of the study information | 2024/10/29 |
| Last modified on | 2025/09/18 16:44:37 |
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Basic information
Public title
Treatment response and transition of anti integrin alpha v beta 6 antibody titers in patients of ulcerative colitis that have newly started treatment
Acronym
V6-VICTOR study
Scientific Title
Treatment response and transition of anti integrin alpha v beta 6 antibody titers in patients of ulcerative colitis that have newly started treatment
Scientific Title:Acronym
V6-VICTOR study
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the treatment response and changes in anti integrin alpha V beta 6 antibody levels in patients who have started treatment with a new 5-ASA preparation, steroids (prednisolone maximum daily dose of 30 mg or more), molecular-targeted drugs, tacrolimus, cyclosporine, or granulocyte and monocyte adsorption apheresis for ulcerative colitis.
Basic objectives2
Others
Basic objectives -Others
To clarify whether there is a correlation between treatment response and anti integrin alpha V beta 6 antibody titer in the treatment of ulcerative colitis.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in anti integrin alpha V beta 6 antibody titers in the clinical remission and non-remission groups 6 to 8 weeks after treatment initiation
Key secondary outcomes
(a) Change in anti integrin alpha V beta 6 antibody titer 6 to 10 weeks after the start of each treatment
(b) Correlation between disease activity and clinical test data at each observation point and anti integrin alpha V beta 6 antibody titer
(c) Clinical remission rate and endoscopic remission rate at 46 to 58 weeks after treatment initiation in the antibody titer decrease group and the antibody titer non decrease group after 2 to 4 and 6 to 10 weeks after treatment initiation
(d) Changes in anti integrin alpha V beta 6 antibody titer in the endoscopic remission group and the endoscopic non remission group after 46 to 58 weeks of treatment
(e) Background factors in the anti integrin alpha V beta 6 antibody titer decrease group and the non-decrease group among cases that achieved clinical remission after 6 to 10 weeks of treatment
(f) Relationship between changes in IgA in feces and anti integrin alpha V beta 6 antibody titers in the clinical remission and non remission groups
(g) Relationship between changes in the expression of genes in peripheral blood mononuclear cells and anti integrin alpha V beta 6 antibody titers in the clinical remission and non remission groups
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are at least 18 years of age at the time of consent
2) Patients who have given their free written consent to participate in the study after receiving full explanation
3) Patients with ulcerative colitis newly treated with 5-ASA, steroids (maximum daily dose of prednisolone >30 mg), molecular targeted drugs, tacrolimus, cyclosporine, granulocyte Patients with ulcerative colitis treated with granulocyte and monocyte adsorption apheresis
Key exclusion criteria
1) Patients with undetermined diagnosis
2) Patients in remission at the start of observation
3) Patients after total colorectal resection
4) Patients with active malignancy
5) Pregnant and lactating patients
6) Patients who have not given consent for this study
7) Patients deemed inappropriate as research subjects by the principal investigator
Target sample size
510
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
hiropynakase@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Shimomori |
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
Homepage URL
shimomori@oita-u.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare of Japan (Investigation and Research for intractable Inflammatory Bowel Disease)
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
Clinical Research Section, Research Support Section, Secretariat, Sapporo Medical University
Address
South 1 West 17, Chuo-ku, Sapporo, Japan
Tel
011-611-2111
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
旭川医科大学 内科学講座 消化器内科学分野（北海道）、岩手医科大学医学部 内科学講座 消化器内科消化管分野（岩手県）、大分大学医学部 消化器内科学講座（大分県）、岡山大学病院 消化器内科（岡山県）、香川県立中央病院 消化器内科（香川県）、関西医科大学附属病院 消化器肝臓内科（大阪府）、京都大学大学院医学研究科 消化器内科学講座（京都府）、杏林大学医学部 消化器内科学（東京都）、佐賀大学医学部 内科学講座 消化器内科（佐賀県）、札幌IBDクリニック（北海道）、札幌東徳洲会病院（北海道）、島根大学医学部 内科学講座 内科学第二（島根県）、東京大学医科学研究所 先端医療開発促進分野／TR・治験センター（東京都）、東邦大学医療センター佐倉病院 消化器内科（千葉県）、鳥取大学医学部 消化器腎臓内科学分野（鳥取県）、富山大学附属病院 炎症性腸疾患内科（富山県）、名古屋大学医学系研究科 消化器内科学（愛知県）、浜松医科大学 内科学第一講座（静岡県）、兵庫医科大学医学部 消化器内科学講座（兵庫県）、弘前大学大学院医学研究科 消化器血液免疫内科学講座（青森県）、福岡大学医学部 消化器内科学講座（福岡県）、福岡大学筑紫病院 消化器内科（福岡県）、愛媛県立中央病院 消化器内科（愛媛県）、愛媛大学医学部 地方消化器免疫学講座（愛媛県）、神戸市立医療センター中央市民病院 消化器内科（兵庫県）、神戸市立西神戸医療センター 消化器内科（兵庫県）、高松赤十字病院（香川県）、筑波大学附属病院 消化器内科（茨城県）、東京医科大学病院 消化器内科（東京都）、東京科学大学病院 消化器内科（東京都）、新潟大学大学院医歯学総合研究科 消化器内科学分野（新潟県）、広島大学病院 消化器内科・内視鏡センター（広島県）、松山赤十字病院 胃腸センター（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Target patients
Patients with ulcerative colitis who were either outpatients or inpatients at Sapporo Medical University Hospital or one of the collaborative research institutions between September 12, 2024 and March 31, 2028
Research Methods
1) to 3) below will involve collecting data from each institution and analyzing it at Sapporo Medical University.
4) to 6) will involve collecting samples at Sapporo Medical University, measuring them at Sapporo Medical University, and then analyzing them.
1) Clinical data
2) Blood test data, stool test data
3) Endoscopy test data
4) Anti integrin alpha v beta 6 antibody titer
5) IgA antibody titer in stool
6) Single cell RNA sequence
Management information
Registered date
| 2024 | Year | 10 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063848
