UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061792 |
|---|---|
| Receipt number | R000068104 |
| Scientific Title | Genetic Mutation Analysis of Lung Cancer Using Intraoperative Tumor Specimens |
| Date of disclosure of the study information | 2026/06/03 |
| Last modified on | 2026/06/03 21:36:46 |
* 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
Genetic Mutation Analysis of Lung Cancer Using Intraoperative Tumor Specimens
Acronym
Genetic Mutation Analysis of Lung Cancer Using Intraoperative Tumor Specimens
Scientific Title
Genetic Mutation Analysis of Lung Cancer Using Intraoperative Tumor Specimens
Scientific Title:Acronym
Genetic Mutation Analysis of Lung Cancer Using Intraoperative Tumor Specimens
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery | Laboratory medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Feasibility of multi-gene mutation testing using lung cancer specimens immediately preserved in RNA stabilization solution after surgical resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection rates of EGFR mutations in preoperative biopsy specimens, intraoperative specimens preserved in an RNA stabilization solution, and intra- and postoperative FFPE specimens
Key secondary outcomes
Detection rates of ALK fusions in preoperative biopsy specimens, intraoperative specimens preserved in an RNA stabilization solution, and intra- and postoperative FFPE specimens
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 20 years or older at the time informed consent was obtained.
2) Patients who underwent surgical treatment for lung cancer.
3) Patients whose preoperative biopsy specimens, intraoperative RNA-preserved specimens, intraoperative FFPE specimens, and/or postoperative FFPE specimens were examined by multigene mutation testing under routine clinical practice covered by health insurance.
4) Patients from whom written informed consent for participation in this study was obtained.
Key exclusion criteria
Pattens who do not fulfill the inclusion criteria.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Tsubochi |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of General Thoracic Surgery
Zip code
330-8503
Address
1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
TEL
048-647-2111
h-tsubochi@omiya.jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Minegishi |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of General Thoracic Surgery
Zip code
330-8503
Address
1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
TEL
048-647-2111
Homepage URL
k-minegishi@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Jichi Medical University Saitama Medical Center Clinical Research Ethics Committee
Address
1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
Tel
048-647-2111
s-suishin@jichi.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NEJ021E
Org. issuing International ID_1
Non-profit organization North East Japan Study Group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 03 | 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 | 17 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2028 | 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:
EGFR mutation detection rate in preoperative biopsy specimens, intraoperative RNA-preserved specimens, and intraoperative or postoperative FFPE specimens.
Secondary endpoints:
ALK fusion gene detection rate in preoperative biopsy specimens, intraoperative RNA-preserved specimens, and intraoperative or postoperative FFPE specimens.
Success rate of genetic testing.
Whether the detection rate of genetic alterations improves according to the number of genetic tests performed.
Management information
Registered date
| 2026 | Year | 06 | Month | 03 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068104
