UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013965
Receipt number R000016265
Scientific Title The study of relationship between fresh macroscopic appearance of tissue specimen obtained by CT-guided biopsy and its clinicopathological feature in NSCLC
Date of disclosure of the study information 2014/05/15
Last modified on 2014/05/15 17:44:35

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Basic information

Public title

The study of relationship between fresh macroscopic appearance of tissue specimen obtained by CT-guided biopsy and its clinicopathological feature in NSCLC

Acronym

The clinicopathologicalstudy of CT-guided biopsy specimens in NSCLC

Scientific Title

The study of relationship between fresh macroscopic appearance of tissue specimen obtained by CT-guided biopsy and its clinicopathological feature in NSCLC

Scientific Title:Acronym

The clinicopathologicalstudy of CT-guided biopsy specimens in NSCLC

Region

Japan


Condition

Condition

non small cell lung cancer

Classification by specialty

Medicine in general Pneumology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the relationship between macroscopic appearance and clonicopathological features.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Frequency of pisitive EMT markers in non small cell lung cancer specimens obtained by CT-guided biopsy

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

18 years-old <=

Age-upper limit

99 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who have a pulmonary lesion, Diagnosed as NSCLC by CT-guided needle biopsy

Key exclusion criteria

Patients who diagnosed except for NSCLC.

Target sample size

111


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsuo Kimura

Organization

Graduate school of medicine, Osaka city university

Division name

Department of respiratory medicine

Zip code


Address

1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan

TEL

06-6645-3611

Email

kimutats@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuo Kimura

Organization

Graduate school of medicine, Osaka city university

Division name

Department of respiratory medicine

Zip code


Address

1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan

TEL

06-6645-3916

Homepage URL


Email

kimutats@med.osaka-cu.ac.jp


Sponsor or person

Institute

Graduate school of medicine, Osaka city university

Institute

Department

Personal name



Funding Source

Organization

Department of Respiratory Medicine, Graduate school of Medicine, Osaka City University

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


Address


Tel


Email



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

2014 Year 05 Month 15 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

2013 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 30 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To examine the relationship the fresh macroscopic appearance with fibrosis and EMT, we performed Azan Staining and immunohistostaining of beta-catenin,E-cadherin,N-cadherin,vimentin, and fibronectin.


Management information

Registered date

2014 Year 05 Month 15 Day

Last modified on

2014 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016265


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name