UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052050 |
|---|---|
| Receipt number | R000059410 |
| Scientific Title | Usefulness of cytology pellets of bronchoscopy for next-generation sequencing (NGS) |
| Date of disclosure of the study information | 2023/09/04 |
| Last modified on | 2024/08/30 15:38:01 |
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Basic information
Public title
Usefulness of cytology pellets of bronchoscopy for next-generation sequencing (NGS)
Acronym
Usefulness of cytology pellets of bronchoscopy for next-generation sequencing (NGS)
Scientific Title
Usefulness of cytology pellets of bronchoscopy for next-generation sequencing (NGS)
Scientific Title:Acronym
Usefulness of cytology pellets of bronchoscopy for next-generation sequencing (NGS)
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluate the success of genetic mutation analysis of specimens collected by bronchoscopy and the usefulness of cytology pellets.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the success rate of genetic mutation analysis by oncomine of specimens obtained from tissue samples and cytology pellets in patients diagnosed with primary lung cancer by bronchoscopy and enrolled in LC-SCRUM-Asia, and to examine the usefulness of the cytology pellet.
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
Patients for whom information on medical treatment and prognosis can be obtained from medical records
Patients enrolled in LC-SCRUM-Asia after bronchoscopy for primary lung cancer at Kobe University Hospital
Patients over 20 years old
Key exclusion criteria
Patients who have requested not to participate in this study based on publicly available information
Target sample size
129
Research contact person
Name of lead principal investigator
| 1st name | Chihiro |
| Middle name | |
| Last name | Mimura |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine,Department of Internal Medicine,
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuou-ku, Kobe, Hyogo
TEL
0783825660
mt0318@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Mimura |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine,
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuou-ku, Kobe, Hyogo
TEL
0783825660
Homepage URL
f9s5m1s3@gmail.com
Sponsor or person
Institute
Kobe University Graduates School of Medicine
Institute
Department
Personal name
Chihiro Mimura
Funding Source
Organization
No
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
KOBE University Hospital Clinical Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuou-ku, Kobe, Hyogo
Tel
078-382-6669
kansatsu@med.kobe-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
| 2023 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
132
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
| 2023 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
In this study, information will be collected retrospectively from medical records.
Management information
Registered date
| 2023 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059410
