UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031497 |
|---|---|
| Receipt number | R000035954 |
| Scientific Title | Histological study of symptomatic neuroma |
| Date of disclosure of the study information | 2018/02/27 |
| Last modified on | 2022/09/01 22:18:17 |
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Basic information
Public title
Histological study of symptomatic neuroma
Acronym
Histological study of symptomatic neuroma
Scientific Title
Histological study of symptomatic neuroma
Scientific Title:Acronym
Histological study of symptomatic neuroma
Region
| Japan |
Condition
Condition
symptomatic neuroma
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine a histology of human symptomatic neuroma
Basic objectives2
Others
Basic objectives -Others
I examine a histology of human symptomatic neuroma and the relation of clinical symptom to reveal the clarify or statement of pain related axon and component cells.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain DETECT and correlation of the number of immunostaining axons.
Key secondary outcomes
1. The correlation of sensation and the number of immunostaining axon.
2. The correlation of skin temperature and the number of immunostaining axon.
3. The correlation of disease duration and the number of immunostaining axon.
4. The correlation of the detail of treatment and the number of immunostaining axon.
5. The correlation of cause of neuroma generation and the number of immunostaining axon.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age over 20 years old.
2. The person obtained imformed consent adequately.
Key exclusion criteria
The patient whom principal investigator judged to be an inapptropriate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Kadoya |
Organization
Hokkaido University
Division name
Department of Orthopaedic Surgery,Faculty of Medicine and Graduate School of Medicine
Zip code
0608638
Address
Kita-ku Kita15 Nishi7 Sapporo Hokkaido
TEL
011-716-1161
kadoya@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Matsui |
Organization
Hokkaido University
Division name
Department of Orthopaedic Surgery, Faculty of Medicine and Graduate School of Medicine
Zip code
0608638
Address
Kita-ku Kita15 Nishi7 Sapporo Hokkaido
TEL
011-716-1161
Homepage URL
yukimatsui0515@yahoo.co.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
The General Insurance Association of Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Clinical Reseach and Medical Innovation Center
Address
Kita-ku Kita15 Nishi7 Sapporo Hokkaido
Tel
011-706-7061
crsupport@huhp.hokudai.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
| 2018 | Year | 02 | Month | 27 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
finished.
Management information
Registered date
| 2018 | Year | 02 | Month | 27 | Day |
Last modified on
| 2022 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035954
