UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060867 |
|---|---|
| Receipt number | R000069654 |
| Scientific Title | Retrospective observational study evaluating the clinical utility of liquid biopsy in cancer genomic profiling for patients with non-small cell lung cancer: impact on treatment recommendation rates, treatment initiation rates, and patient characteristics. |
| Date of disclosure of the study information | 2026/05/10 |
| Last modified on | 2026/03/08 21:26:50 |
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Basic information
Public title
Retrospective observational study evaluating the clinical utility of liquid biopsy in cancer genomic profiling for patients with non-small cell lung cancer: impact on treatment recommendation rates, treatment initiation rates, and patient characteristics.
Acronym
Investigation on the contribution of liquid biopsy to treatment in cancer genomic profiling for patients with non-small cell lung cancer
Scientific Title
Retrospective observational study evaluating the clinical utility of liquid biopsy in cancer genomic profiling for patients with non-small cell lung cancer: impact on treatment recommendation rates, treatment initiation rates, and patient characteristics.
Scientific Title:Acronym
Real-world utility of liquid biopsy in NSCLC CGP
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the clinical utility of liquid biopsy-based cancer genomic profiling in patients with non-small cell lung cancer, specifically focusing on patient background factors that contribute to treatment recommendations and actual treatment delivery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment recommendation rate
Key secondary outcomes
Treatment delivery rate, Genomic alteration detection rate, number of detected variants, ctDNA non-detection rate, overall survival stratified by the presence or absence of treatment recommendations based on liquid CGP, analysis of reasons for treatment non-delivery in patients who received treatment recommendations, and patient background factors immediately prior to liquid CGP for patients with treatment recommendations (treatment line, PS, maximum tumor diameter, number of metastatic sites, presence or absence of liver and brain metastases, LDH, CRP, NLR, WBC, and neutrophil count)
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 with non-small cell lung cancer aged 20 years or older at the time of testing, who underwent liquid biopsy-based cancer genomic profiling at Tohoku University Hospital between January 2019 and March 2026.
Key exclusion criteria
Patients judged inappropriate for the study by the principal or sub-investigator at each institution (e.g., due to a lack of essential clinical data required for analysis).
Patients who declined to participate in the study through the opt-out process.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Eisaku |
| Middle name | |
| Last name | Miyauchi |
Organization
Tohoku University Hospital
Division name
Department of Respiratory Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8539
chikashi.iwasaki.e3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Chikashi |
| Middle name | |
| Last name | Iwasaki |
Organization
Tohoku University Hospital
Division name
Department of Respiratory Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8539
Homepage URL
chikashi.iwasaki.e3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funded
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
Ethics Committee, Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-8132
eth-office@med.tohoku.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
| 2026 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is part of a series of clinical investigations on the real-world utility of cancer genomic medicine at Tohoku University Hospital.
Management information
Registered date
| 2026 | Year | 03 | Month | 08 | Day |
Last modified on
| 2026 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069654
