UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053066 |
|---|---|
| Receipt number | R000060472 |
| Scientific Title | Clinical Study to Evaluate Anti-NF155 Antibody ELISA Kit and Anti-CNTN1 Antibody ELISA Kit for Patients with IgG4 Autoantibody-Positive CIDP |
| Date of disclosure of the study information | 2023/12/28 |
| Last modified on | 2023/12/11 16:02:46 |
* 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
Clinical Study to Evaluate Anti-Neurofascin 155 Antibody ELISA Kit and Anti-Contactin 1 Antibodies ELISA Kit for Patients with IgG4 Autoantibody-Positive Chronic Inflammatory Demyelinating Polyneuropathy
Acronym
Clinical Study to Evaluate Anti-NF155 Antibody ELISA Kit and Anti-CNTN1 Antibody ELISA Kit for Patients with IgG4 Autoantibody-Positive CIDP
Scientific Title
Clinical Study to Evaluate Anti-NF155 Antibody ELISA Kit and Anti-CNTN1 Antibody ELISA Kit for Patients with IgG4 Autoantibody-Positive CIDP
Scientific Title:Acronym
Clinical Study to Evaluate Anti-NF155 Antibody ELISA Kit and Anti-CNTN1 Antibody ELISA Kit for Patients with IgG4 Autoantibody-Positive CIDP
Region
| Japan |
Condition
Condition
IgG4 Autoantibody-Positive Chronic Inflammatory Demyelinating Polyneuropathy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the clinical performance of Anti-NF155 Antibody ELISA Kit and Anti-CNTN1 Antibody ELISA Kit by the comparison study with cell-based immunoassays.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Positive percent agreement, Negative percent agreement and Overall percent agreement are all not lower than 90 percent.
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Pat ients with CIDP diagnosed according to the modified diagnostic criteria of the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) (2010) .
2. Patients with written consent from themselves or their legal representatives.
3. Patients aged 12 years or older at informed consent.
Key exclusion criteria
1. Patients with symptoms of anemia (hemoglobin less than 8 g/dl).
2. Patients judged to be unsuitable by the investigator or a sub-investigator.
Target sample size
370
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Isobe |
Organization
Kyushu University Hospital
Division name
Department of Neurology
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-641-1151
isobe.noriko.342@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Ogata |
Organization
Kyushu University Hospital
Division name
Department of Neurology
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-641-1151
Homepage URL
ogata.hidenori.565@m.kyushu-u.ac.jp
Sponsor or person
Institute
YAMASA CORPORATION
Institute
Department
Personal name
Funding Source
Organization
YAMASA CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiba University Hospital, Nagoya University Hospital, Kindai University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Boards / Ethics Committees of Kyushu University Hospital and Medical Institutions
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
Tel
N/A
N/A
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 | 12 | Month | 28 | 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
| 2022 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | 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
None
Management information
Registered date
| 2023 | Year | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060472
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
