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 |
* 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
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
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
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
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
