UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057406 |
|---|---|
| Receipt number | R000065594 |
| Scientific Title | Molecular Profiling and Biomarker analysis in Resectable Non-small Lung Cancer for Precision Perioperative Therapy |
| Date of disclosure of the study information | 2025/03/26 |
| Last modified on | 2025/06/26 15:23:13 |
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Basic information
Public title
Molecular Profiling and Biomarker analysis in Resectable Non-small Lung Cancer for Precision Perioperative Therapy
Acronym
MERCURY
Scientific Title
Molecular Profiling and Biomarker analysis in Resectable Non-small Lung Cancer for Precision Perioperative Therapy
Scientific Title:Acronym
MERCURY
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to analyze molecular profiling at the genomic, transcriptomic, and protein levels in cancer and immune cells from blood and tissue samples of resectable non-small cell lung cancer (NSCLC) cases. By integrating these findings with clinical data, the study seeks to identify biomarkers reflecting the molecular biological characteristics of resectable NSCLC.
Basic objectives2
Others
Basic objectives -Others
Primary endpoints
Correlation of molecular profiles, including genetic abnormalities, RNA expression, immune cell phenotypes, and minimal residual disease (MRD) in peripheral blood and tumor tissue with recurrence and prognosis.
Secondary endpoints
Relationships among molecular profiles, treatment outcomes, clinical-pathological factors such as treatment course, imaging findings, and pathological observations.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of molecular profiles, including genetic abnormalities, RNA expression, immune cell phenotypes, and minimal residual disease (MRD) in peripheral blood and tumor tissue with recurrence and prognosis.
Key secondary outcomes
Relationships among molecular profiles, treatment outcomes, clinical-pathological factors such as treatment course, imaging findings, and pathological observations.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age 18 years or older at the time of obtaining consent
2) Participants with resectable clinical stage I -III non-small cell lung cancer
3) The following treatments are planned at the participating institutions:
Cohort A : Neoadjuvant treatment cohort
Cohort B: Up-front surgery Cohort
4) ECOG Performance Status of 0 or 1
5) Written informed consent has been obtained from the participant for participation in this study.
Key exclusion criteria
1)Presence of active co-occurring malignancies
2) Pregnant
3) Have undergone hematopoietic stem cell transplantation
4) Any other cases deemed unsuitable for inclusion in this study by the principal investigator or sub-investigator.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Tsuboi |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
mtsuboi@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Nomura |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
Homepage URL
kotnomur@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital East
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
iTMS Co., Ltd.
Name of secondary funder(s)
Tempus AI, Inc.
Department of Respiratory Medicine, Saitama Medical University International Medical Center
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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 | 03 | Month | 26 | 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
| 2025 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2030 | 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 aims to analyze molecular profiling at the genomic, transcriptomic, and protein levels in cancer and immune cells from blood and tissue samples of resectable non-small cell lung cancer (NSCLC) cases. By integrating these findings with clinical data, the study seeks to identify biomarkers reflecting the molecular biological characteristics of resectable NSCLC.
Management information
Registered date
| 2025 | Year | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065594
