UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054164 |
|---|---|
| Receipt number | R000061852 |
| Scientific Title | A retrospective observational study to examine the reality of potential driver gene false negatives in non-small cell lung cancer patients |
| Date of disclosure of the study information | 2024/04/16 |
| Last modified on | 2024/04/16 10:48:18 |
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Basic information
Public title
A retrospective observational study to examine the reality of potential driver gene false negatives in non-small cell lung cancer patients
Acronym
A retrospective observational study of rare driver gene false negatives in lung cancer
Scientific Title
A retrospective observational study to examine the reality of potential driver gene false negatives in non-small cell lung cancer patients
Scientific Title:Acronym
A retrospective observational study of rare driver gene false negatives in lung cancer
Region
| Japan |
Condition
Condition
non small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify the results of analysis of cancer-related genes (types and frequency of genetic abnormalities) obtained from the Oncomine Dx Target Test Multi-CDx System (ODxTT) in lung cancer patients previously treated at our hospital and the types and frequency of driver genes that are potentially missed in the analysis pipeline of the ODxTT. To clarify.
Basic objectives2
Others
Basic objectives -Others
To identify the types and frequencies of driver genes that are potentially missed in the analysis of cancer-related genes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Type and frequency of driver genes that are reported as negative in the ODxTT analysis pipeline but can be detected by examining the Binary Alignment/Map (BAM) file.
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
Patients who have given written consent for the secondary use of genomic data and clinical information for research when the ODxTT test, FoundationOne, and FoundationOne Liquid are performed.
Key exclusion criteria
No exclusion criteria.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Takahama |
Organization
KINDAI University Hospital
Division name
Genome Medical Center
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-Sayama City, Osaka
TEL
072-366-0221
takahama_t@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Shiraishi |
Organization
KINDAI University Hospital
Division name
Genome Medical Center
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-Sayama City, Osaka
TEL
072-366-0221
Homepage URL
naoki-shiraishi@med.kindai.ac.jp
Sponsor or person
Institute
KINDAI university
Institute
Department
Personal name
Funding Source
Organization
KINDAI university
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
Kindai university faculty of medicine of Ethics Committe
Address
377-2 Ohonohigashi Osaka-sayama city Osaka Japan
Tel
072-366-0221
zizen@med.kindai.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
| 2024 | Year | 04 | Month | 16 | 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
Suspended
Date of protocol fixation
| 2023 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical information will be obtained from medical records for cases in which written consent for secondary use of genomic data and clinical information for research is obtained when ODxTT testing, FoundationOne, and FoundationOne Liquid are performed.
For the ODxTT test, genomic analysis will be performed as necessary using BAM files in cases where results are obtained.
Note that these clinical information and sequence data have already been obtained in general practice and will not be newly collected for the purpose of this study.
Management information
Registered date
| 2024 | Year | 04 | Month | 16 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061852
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
