UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050519 |
|---|---|
| Receipt number | R000057110 |
| Scientific Title | A Clinical Study to Evaluate the Reliability and Validity of the Japanese Version of the Crohn's Anal Fistula Quality of Life scale (CAF-QoL) |
| Date of disclosure of the study information | 2023/03/10 |
| Last modified on | 2024/09/05 15:25:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Clinical Study to Evaluate the Reliability and Validity of the Japanese Version of the Crohn's Anal Fistula Quality of Life scale (CAF-QoL)
Acronym
A Clinical Study to Evaluate the Reliability and Validity of the Japanese Version of the Crohn's Anal Fistula Quality of Life scale (CAF-QoL)
Scientific Title
A Clinical Study to Evaluate the Reliability and Validity of the Japanese Version of the Crohn's Anal Fistula Quality of Life scale (CAF-QoL)
Scientific Title:Acronym
A Clinical Study to Evaluate the Reliability and Validity of the Japanese Version of the Crohn's Anal Fistula Quality of Life scale (CAF-QoL)
Region
| Japan |
Condition
Condition
Crohn's Anal Fistula
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the reliability of the CAF-QoL Japanese version
To evaluate the validity of the CAF-QoL Japanese version
Basic objectives2
Others
Basic objectives -Others
To evaluate theCAF-QoL responsiveness (longitudinal validity) of the CAF-QoL Japanese version
To explore the interpretation of CAF-QoL scores
To explore factors affecting QoL in patients with Crohn's disease and anal fistulas
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CAF-QoL, PDAI, HBI, SIBDQ, QDIS, HADS scores
Key secondary outcomes
Longitudinal CAF-QoL, PDAI, HBI, SIBDQ, QDIS, HADS scores
Physician-report and patient reported changes
CAF-QoL, PDAI, HBI, SIBDQ, QDIS, HADS, Van-Assche Index scores (as for Van-Assche scores, only when MRI data was obtained as part of clinical practice during 1 month before baseline or the study period)
Patient demographic and medical history data
Patient-reported disease related information
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. The subjects are capable of understanding the study and questionnaire and complying with the protocol in the opinion of the investigator or subinvestigator.In the opinion of the investigator or sub-investigator, the subject is capable of understanding the study and questionnaire and complying with protocol requirements.
2. The subject signs and dates a written, informed consent form prior to the initiation of any study procedures.
3. The subject is aged 18 years or older at the time of informed consent.
4. At baseline, Tthe subject has a definite diagnosis of Crohn's disease and anal fistulas as a complication of Crohn's disease assessed by a specialist.
The subject has a symptomatic* fistula(s) at baseline
*Symptomatic: anal fistulas with any level of perianal symptoms. All patients with seton will be eligible.
5. The subject is a native speaker of Japanese or has a comparable language ability of a native speaker based on the judgement of the physician.
Key exclusion criteria
1. The subject with completely closed fistulas at baseline
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Ikeuchi |
Organization
Hyogo Medical University
Division name
Division of Inflammatory Bowel Disease Surgery, Department of Gastroenterological Surgery
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
TEL
0798-45-6111
ikeuci2s@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Mizoguchi |
Organization
A2 Healthcare Corporation
Division name
Clinical Development Division Clinical Development Department 4
Zip code
112-0002
Address
Sumitomo Fudosan Korakuen Bldg. 1-4-1, Koishikawa, Bunkyo-Ku, Tokyo, Japan
TEL
03-3830-1075
Homepage URL
mizoguchi-m@a2healthcare.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University
Address
1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
Tel
079-845-6111
rinsys@hyo-med.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | 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
103
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
| 2022 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This clinical study is a multicenter prospective observational study to evaluate the reliability and validity of the Japanese version of the CAF-QoL Japanese version in patients with anal fistulas associated with Crohn's disease.
After informed consent to participate in the study is obtained from the subject, each a questionnaire will be completed by the subject and their physician (this time point of first data collection will be defined as baseline). TheA second questionnaire will also be completed by the subject 14 days after baseline (second data collection), and again by the subject and physician 60 days after baseline (third data collection). In total, the subject will answer the questionnaire maximum 3 times, and physician will answer twice. Additional medical information (demographic data, medical history, drug therapy and surgical treatment for Crohn's disease and anal fistula of Crohn's disease, etc.) will be collected from medical records by the research team at Point 1 and 3.
Management information
Registered date
| 2023 | Year | 03 | Month | 07 | Day |
Last modified on
| 2024 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057110
