UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025724
Receipt number R000029584
Scientific Title A novel technique for cellular diagnosis utilizing scanning electron microscope.
Date of disclosure of the study information 2017/01/24
Last modified on 2020/05/12 12:14:40

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Basic information

Public title

A novel technique for cellular diagnosis utilizing scanning electron microscope.

Acronym

A novel technique utilizing scanning electron microscope.

Scientific Title

A novel technique for cellular diagnosis utilizing scanning electron microscope.

Scientific Title:Acronym

A novel technique utilizing scanning electron microscope.

Region

Japan


Condition

Condition

thoracic malignancy

Classification by specialty

Chest surgery Laboratory medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To verify the distinguishability of tumor cells by intracellular observation and elemental analysis method using tabletop electron microscope

Basic objectives2

Others

Basic objectives -Others

distinguishability of tumor cells

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

distinguishability of tumor cells

Key secondary outcomes

background factor
optimal observation method


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

Patients who underwent surgery for diseases that had been suspected thoracic malignancy in National Cancer Center Hospital from May 2015 to July 2016.
Patients who agreed the comprehensive content.

Key exclusion criteria

not applicable

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name Matsumoto

Organization

National Cancer Center Hospital

Division name

Department of Endoscopy, Respiratory Endoscopy Division

Zip code

104-0045

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

TEL

03-3542-2511

Email

yumatsum@ncc.go.jp


Public contact

Name of contact person

1st name Yuji
Middle name
Last name Matsumoto

Organization

National Cancer Center Hospital

Division name

Department of Endoscopy, Respiratory Endoscopy Division

Zip code

104-0045

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

TEL

03-3542-2511

Homepage URL


Email

yumatsum@ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Hitachi Ltd.
Hitachi High-Technologies

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Cancer Center Institutional Review Board

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

Tel

03-3542-2511

Email

irst@ml.res.ncc.go.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 01 Month 24 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

2016 Year 12 Month 27 Day

Date of IRB

2016 Year 09 Month 17 Day

Anticipated trial start date

2017 Year 01 Month 25 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

not applicable


Management information

Registered date

2017 Year 01 Month 18 Day

Last modified on

2020 Year 05 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029584


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name