UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056869 |
|---|---|
| Receipt number | R000064969 |
| Scientific Title | MINtS Real-World Analysis: Annual Trends in Gene Mutation Detection Rates by Sample Type, Sample Collection Method, and Extracted Nucleic Acid Quantity Using the MINtS Multi-Gene Mutation Test |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2025/01/30 10:10:33 |
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Basic information
Public title
MINtS Real-World Analysis: Annual Trends in Gene Mutation Detection Rates by Sample Type, Sample Collection Method, and Extracted Nucleic Acid Quantity Using the MINtS Multi-Gene Mutation Test
Acronym
MINtS Real-World Analysis
Scientific Title
MINtS Real-World Analysis: Annual Trends in Gene Mutation Detection Rates by Sample Type, Sample Collection Method, and Extracted Nucleic Acid Quantity Using the MINtS Multi-Gene Mutation Test
Scientific Title:Acronym
MINtS Real-World Analysis
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Answer the following questions: What is the optimal sample for genetic mutation testing that can be collected in a real clinical environment? What are the collection techniques that can be used to obtain the optimal sample?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gene mutation detection rates by histological type, sample type, and extracted nucleic acid quantity
Key secondary outcomes
Nucleic acid quantity and gene mutation detection rates by collection technique, the estimated proportion of carcinogenic driver mutations in lung cancer in Japan based on the primary endpoint, and the temporal changes in the primary endpoint
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 who consent to the collection, analysis, and presentation of data on pathological type, specimen type, extracted nucleic acid amount, specimen collection technique, and genetic mutation test results, under the condition that their personal information remains undisclosed, while MINtS is performed in the context of insurance-covered medical care
Key exclusion criteria
Patients who do not fulfill the inclusion criteria
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Kage |
Organization
The University of Tokyo hospital
Division name
Respiratory Medicine
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
kageh-int@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Kawakami |
Organization
The University of Tokyo Hospital
Division name
Respiratory Medicine
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
0338155411
Homepage URL
kawakamim-int@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jichi Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
0338155411
ethics@m.u-tokyo.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
| 2025 | Year | 02 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
primary endpoint: Gene mutation detection rates by histological type, sample type, and extracted nucleic acid quantity
Management information
Registered date
| 2025 | Year | 01 | Month | 30 | Day |
Last modified on
| 2025 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064969
