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| ID | Type | Description | Link |
|---|---|---|---|
| 2021.0156 | Other Grant/Funding Number | Fondazione Cassa di Risparmio Bologna |
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The study aim to evaluate whether some substances produced by muscle or adipose tissue may play a role in the course of the disease by interfering with the effectiveness of therapies.
The study is aimed at patients with NSCLC in whom plasma levels of particular biomarkers will be studied before and after treatment with chemotherapy and immunotherapy or immunotherapy alone.
In particular, the plasma levels of GDF15, FGF21, HN, Activin molecules and microRNAs involved in inflammatory processes, called inflammamiR, in particular of microRNA146, 126, 21, 188, 155, will be studied.
Assessments of cellular markers of leukocyte aging will also be performed (determination of telomere length is a widely used measure of biological aging)
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| Measure | Description | Time Frame |
|---|---|---|
| Study of serum levels of molecules functionally involved in cachexia/anorexia and sarcopenia, markers of inflammation and markers of aging in patients with NSCLC | To determine the plasma levels of GDF15, FGF21, some microRNAs involved in inflammatory processes called inflammamiR and to perform the measurement of telomere length in leukocytes in plasma samples of patients with NSCLC before and after treatment with chemotherapy and immunotherapy or immunotherapy alone. The association between variables of clinical interest and plasma levels of the aforementioned molecules will be evaluated. In particular, the association between their plasma levels and body composition expressed as a percentage of fat mass and lean mass and overall-survival (OS) and progression-free survival (PFS) will be evaluated. | The concentration of the respective molecules between the baseline sample and the sample taken after 3 months of treatment will be compared |
| Measure | Description | Time Frame |
|---|---|---|
| Flow cytometric analysis of immunosenescence markers in lymphocytes of patients with NSCLC. | The leukocyte subpopulations of interest (cell. T naïve, cell. T of the central memory, cell. T of effector memory, cell. Suppressive Myeloids, cell. NK) will be reported as percentages per sample. The association between variables of clinical interest and the percentage of different leukocyte subpopulations will be evaluated. The association between percentages of white blood cell subpopulations and OS, PFS will be evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with NSCLC diagnosis in advanced stage, who are eligibble to receive a treatment with single-agent immunotherapy, or a chemo-immunotherapy combination
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Ardizzoni, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055948 | Sarcopenia |
| D002100 | Cachexia |
| D000855 | Anorexia |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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plasma samples
| The percentage of the different subpopulations between the baseline sample and the sample taken after 3 months of treatment will be compared. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D013851 | Thinness |
| D012817 | Signs and Symptoms, Digestive |