UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059363 |
|---|---|
| Receipt number | R000067874 |
| Scientific Title | Exploration of Molecular Biomarkers Predictive of Adverse Events and Therapeutic Efficacy in Patients with Thoracic Malignancies |
| Date of disclosure of the study information | 2025/10/10 |
| Last modified on | 2025/10/10 11:36:53 |
* 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
A Study to Identify Biomarkers That Can Predict the Effectiveness and Side Effects of Cancer Treatment in Patients with Thoracic Tumors
Acronym
Molecular Biomarker Study of Thoracic Cancer
Scientific Title
Exploration of Molecular Biomarkers Predictive of Adverse Events and Therapeutic Efficacy in Patients with Thoracic Malignancies
Scientific Title:Acronym
Molecular Biomarker Study of Thoracic Malignancies
Region
| Japan |
Condition
Condition
Lung cancer, thymic carcinoma, thymoma, and malignant pleural mesothelioma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore blood and pleural effusion biomarkers predictive of adverse events associated with thoracic malignancy treatments, including cytotoxic chemotherapy, molecular targeted therapy, immune checkpoint inhibitors, antibody-drug conjugates, bispecific antibodies, bispecific T-cell engagers, and thoracic radiotherapy.
Basic objectives2
Others
Basic objectives -Others
Biomarker exploration
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between the occurrence of grade >=2 adverse events (according to CTCAE v5.0), stratified by clinically relevant adverse events previously reported for each treatment modality of thoracic malignancies (cytotoxic chemotherapy, molecular targeted therapy, immune checkpoint inhibitors, antibody-drug conjugates, bispecific antibodies, bispecific T-cell engagers, and radiotherapy), and both baseline serum biomarker levels and their changes at 3-4 weeks after treatment initiation.
Key secondary outcomes
To evaluate the associations between the occurrence of adverse events and therapeutic efficacy (objective response rate, progression-free survival, and overall survival) during treatment for thoracic malignancies and (i) serum and pleural fluid concentrations of humoral biomarkers, (ii) molecular marker expression in leukocytes from peripheral blood, pleural effusion, and tumor tissue, and (iii) natural killer (NK) cell activity at baseline and their relative changes at 3-4 weeks after treatment initiation.
To assess the associations between the occurrence of adverse events and therapeutic efficacy (objective response rate, progression-free survival, and overall survival) during treatment for thoracic malignancies and the expression levels of NKG2D ligands in pretreatment tumor tissues.
To compare serum and pleural fluid concentrations of humoral biomarkers, molecular marker expression in leukocytes from blood, pleural effusion, and tumor tissue, and NK cell activity among patients with thoracic malignancies (at pretreatment, 3-4 weeks after treatment initiation, and at the onset of adverse events) and control groups consisting of individuals with non-malignant respiratory diseases, autoimmune diseases, allergic diseases, infectious diseases, thoracic malignancy patients not scheduled for anticancer therapy or radiotherapy, and healthy volunteers.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 16 years or older at the time of consent who are diagnosed with thoracic malignancies (lung cancer, thymic carcinoma, thymoma, or malignant pleural mesothelioma) and are scheduled to receive treatment with cytotoxic chemotherapy, molecular targeted agents, immune checkpoint inhibitors, antibody-drug conjugates, bispecific antibodies, bispecific T-cell engagers, or thoracic radiotherapy at the Division of Respiratory Medicine and Rheumatology, Tottori University Hospital.
As control groups, patients aged 16 years or older at the time of consent who are diagnosed and treated at the Division of Respiratory Medicine and Rheumatology, Tottori University Hospital for non-malignant respiratory diseases, autoimmune diseases, allergic diseases, or infectious diseases, as well as those with thoracic malignancies not scheduled to undergo anticancer drug therapy or radiotherapy. In addition, healthy volunteers aged 18 years or older at the time of consent will be included.
Key exclusion criteria
Patients who do not have samples required for the evaluation of this study, those who decline the use of their samples or information, and those whom the principal investigator judges to be inappropriate for participation in the study.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tottori University
Division name
Division of Respiratory Medicine and Rheumatology, Faculty of Medicine
Zip code
6838504
Address
36-1 Nishi-cho, Yonago, Tottori, Japan
TEL
0859386537
kske2@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tottori University
Division name
Division of Respiratory Medicine and Rheumatology, Faculty of Medicine
Zip code
6838504
Address
36-1 Nishi-cho, Yonago, Tottori
TEL
0859386537
Homepage URL
kske2@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Kosuke Yamaguchi
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Faculty of Medicine, Tottori University
Address
36-1 Nishi-cho, Yonago, Tottori, Japan
Tel
0859387014
me-rinshoukenkyu@ml.adm.tottori-u.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
Tottori
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study analyzing the relationship between adverse events and biomarkers using clinical information and biological samples from patients with thoracic malignancies. No therapeutic intervention is performed. The study also includes retrospective analyses using previously collected samples and data from our past clinical studies under an opt-out consent procedure.
Management information
Registered date
| 2025 | Year | 10 | Month | 10 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067874
