UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041699
Receipt number R000047599
Scientific Title Comparison of Transbronchial Cryobiopsy Samples with Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Samples in Adequacy for Next-Generation Sequencing Analysis
Date of disclosure of the study information 2020/09/05
Last modified on 2020/09/05 15:13:28

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Basic information

Public title

Comparison of Transbronchial Cryobiopsy Samples with Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Samples in Adequacy for Next-Generation Sequencing Analysis

Acronym

Comparison of Transbronchial Cryobiopsy Samples with Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Samples in Adequacy for Next-Generation Sequencing Analysis

Scientific Title

Comparison of Transbronchial Cryobiopsy Samples with Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Samples in Adequacy for Next-Generation Sequencing Analysis

Scientific Title:Acronym

Comparison of Transbronchial Cryobiopsy Samples with Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Samples in Adequacy for Next-Generation Sequencing Analysis

Region

Japan


Condition

Condition

lung caner

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

I order to report comparison of TBLC samples with EBUS-TBNA samples in adequacy for NGS analysis in clinical practice.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The adequacy for NGS analysis in TBLC samples.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

This retrospective cohort study included patients whose lung samples were analyzed by NGS system for detecting driver gene mutations between June 2019 and July 2020 at the Japanese Red Cross Medical Center. The lung samples were collected by TBLC or EBUS-TBNA at our institution.

Key exclusion criteria

The lung samples were collected by other procedures than TBLC and EBUS-TBNA.

Target sample size

37


Research contact person

Name of lead principal investigator

1st name Mari
Middle name
Last name Tone

Organization

Japanese Red Cross Medical Center

Division name

Department of Respiratory Medicine

Zip code

150-8935

Address

4-1-22 Hiroo, Shibuya, Tokyo

TEL

03-3400-1311

Email

m.tone.0829@gmail.com


Public contact

Name of contact person

1st name Mari
Middle name
Last name Tone

Organization

Japanese Red Cross Medical Center

Division name

Department of Respiratory Medicine

Zip code

150-8935

Address

4-1-22 Hiroo, Shibuya, Tokyo

TEL

03-3400-1311

Homepage URL


Email

m.tone.0829@gmail.com


Sponsor or person

Institute

Japanese Red Cross Medical Center

Institute

Department

Personal name



Funding Source

Organization

No

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

Japanese Red Cross Medical Center

Address

4-1-22 Hiroo, Shibuya, Tokyo

Tel

03-3400-1311

Email

m.tone.0829@gmail.com


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

2020 Year 09 Month 05 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

37

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

2019 Year 06 Month 01 Day

Date of IRB

2020 Year 05 Month 20 Day

Anticipated trial start date

2019 Year 06 Month 01 Day

Last follow-up date

2020 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is an observational study with no intervention. We collected data from patients' medical charts.


Management information

Registered date

2020 Year 09 Month 05 Day

Last modified on

2020 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047599


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name