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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name