Lung cancer, thymic carcinoma, thymoma, and malignant pleural mesothelioma
Conditions
Interventions
None listed
Sponsors
Tottori University
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKosuke Yamaguchi
Tottori University Division of Respiratory Medicine and Rheumatology, Faculty of Medicine
Outcome results
None listed