UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042838 |
|---|---|
| Receipt number | R000048904 |
| Scientific Title | Observational study of the relationship between tissue preservation status and success rate of Oncomine Dx Target Test Multi-CDx system in lung cancer |
| Date of disclosure of the study information | 2020/12/25 |
| Last modified on | 2022/08/14 11:41:37 |
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Basic information
Public title
Observational study of the relationship between tissue preservation status and success rate of Oncomine Dx Target Test Multi-CDx system in lung cancer
Acronym
Observational study of the relationship between tissue preservation status and success rate of Oncomine DxTT in lung cancer
Scientific Title
Observational study of the relationship between tissue preservation status and success rate of Oncomine Dx Target Test Multi-CDx system in lung cancer
Scientific Title:Acronym
Observational study of the relationship between tissue preservation status and success rate of Oncomine DxTT in lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer (NSCLC)
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify optimal method for storing surgical specimens for NGS by comparing the Oncomine Dx Target Test Multi-CDx system results when the excised specimen of the same patient is fixed with formalin immediately after excision and the excised specimen is stored in a refrigerator and fixed with formalin after surgery.
Basic objectives2
Others
Basic objectives -Others
Success rate of gene mutation measurement
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nucleic acid recovery amount and analysis results by Oncomine Dx Target Test Multi-CDx system
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Cases of lung cancer resection surgery performed at the Osaka International Cancer Institute after February 2020
2.Cases in which there are both samples that were formalin-fixed immediately after lung cancer resection and samples that were refrigerated and formalin-fixed after surgery.
3.Written informed consent after sufficient explanation.
Key exclusion criteria
None
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazumi |
| Middle name | |
| Last name | Nishino |
Organization
Osaka International Cancer Institute
Division name
Thoracic Oncology
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku Osaka city, Japan
TEL
06-6945-1181
kazumi.nishino@oici.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Kunimasa |
Organization
Osaka International Cancer Institute
Division name
Thoracic Oncology
Zip code
5418567
Address
3-1-69 Otemae, Chuo-ku Osaka city, Japan
TEL
0669451181
Homepage URL
kei.kunimasa@oici.jp
Sponsor or person
Institute
Department of Thoracic Oncology,
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Department of Thoracic Oncology,
Osaka International Cancer Institute
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
Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-ku Osaka city, Japan
Tel
06-6945-1181
rinri01@opho.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
大阪国際がんセンター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 25 | 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
17
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
in the process of being written
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2020 | Year | 12 | Month | 24 | Day |
Last modified on
| 2022 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048904
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
