UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028837
Receipt number R000033005
Scientific Title Study of differences in infrared light meibography findings between sebaceous gland carcinoma and chalazion
Date of disclosure of the study information 2017/08/31
Last modified on 2020/08/28 19:52:10

* 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

Study of differences in infrared light meibography findings between sebaceous gland carcinoma and chalazion

Acronym

Study of differences in infrared light meibography findings between sebaceous gland carcinoma and chalazion

Scientific Title

Study of differences in infrared light meibography findings between sebaceous gland carcinoma and chalazion

Scientific Title:Acronym

Study of differences in infrared light meibography findings between sebaceous gland carcinoma and chalazion

Region

Japan


Condition

Condition

eyelid sebaceous gland carcinoma, chalazion

Classification by specialty

Ophthalmology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

defferences in inflared light meibography findings between sebaceous gland carcinoma and chalazion

Basic objectives2

Others

Basic objectives -Others

find the method to make diffencial diagnosis of eyelid sebaceous gland carcinoma and chalazion

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the strength of infrared light reflex of sebaceouc gland carcionma and chalazion

Key secondary outcomes

age, sex, duration of condition, pathological diagnosis


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

diagnosis chalazion or eyelid sebaceous gland carcinoma

Key exclusion criteria

no meibography examination before treatment

Target sample size

83


Research contact person

Name of lead principal investigator

1st name Koh-hei
Middle name
Last name Sonoda

Organization

Kyushu University

Division name

Graduate school of medicineDepartment of ophthalmology

Zip code

812-8533

Address

Fukuoka city Higashiku maidashi 3-1-1

TEL

092-642-5648

Email

sonodak@eye.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Ken-ichi
Middle name
Last name Takaki

Organization

Kyushu University

Division name

Graduate school of medicineDepartment of ophthalmology

Zip code

812-8533

Address

Fukuoka city Higashiku maidashi 3-1-1

TEL

092-642-5648

Homepage URL


Email

mblactak@eye.med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu University

Institute

Department

Personal name



Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional review board fot clinical trials of Kyushu-University Hospital

Address

Fukuoka city Higashiku maidashi 3-1-1

Tel

092-642-5082

Email

bynintei@jimu.kyushu-u.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

2017 Year 08 Month 31 Day


Related information

URL releasing protocol

http://www.eye.med.kyushu-u.ac.jp/

Publication of results

Unpublished


Result

URL related to results and publications

http://www.eye.med.kyushu-u.ac.jp/

Number of participants that the trial has enrolled

83

Results

differences in infrared light reflex strength between eyelid sebaceous gland carcinoma and chalazion

Results date posted

2020 Year 08 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

67 chalazion patients
16 Sebaceous carcinoma patients

Participant flow

Clinical or pathological daiagnosis of chalazion or sebaceous carcinoma with the examination of
meibography

Adverse events

no Adverse events

Outcome measures

diagnosis
meibography findings

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2011 Year 01 Month 01 Day

Date of IRB

2020 Year 04 Month 01 Day

Anticipated trial start date

2011 Year 01 Month 01 Day

Last follow-up date

2023 Year 09 Month 29 Day

Date of closure to data entry

2023 Year 09 Month 30 Day

Date trial data considered complete

2023 Year 09 Month 30 Day

Date analysis concluded

2023 Year 12 Month 31 Day


Other

Other related information

Age, sex, sixteen eyelid sebaceous carcionma patients, and 67 chalazion patients


Management information

Registered date

2017 Year 08 Month 25 Day

Last modified on

2020 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033005


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name