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This is a blood collection study being conducted to better understand and describe the immunological blood profile changes in patients with advanced non small cell lung cancer undergoing treatment with checkpoint inhibitor therapy. Blood will be collected from healthy volunteers and patients with non small cell lung cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Group | Healthy volunteers will donate a sample of blood to be used as controls | ||
| NSCLC Group | Patients with advanced NSCLC will have blood collected prior to treatment and after completing 3 cycles of immune checkpoint therapy. . If a patient is noted to have progressive disease after 2 cycles of treatment, a sample will be collected after the 2nd cycle. If a patient is noted to have pseudoprogression (determined at the discretion of the treating physician), an additional sample may be collected after 3 cycles of therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in myeloid derived suppressive cells (MDSCs) | change in MDSCs before and after treatment | baseline and cycle 3 |
| Mean change in B regulatory cells (Bregs) | change in Bregs before and after treatment | baseline and cycle 3 |
| Mean change in T regulatory cells (Tregs) before and after treatment | change in Tregs before and after treatment | baseline and cycle 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the programmed death-ligand 1 (PD-L1) expression profile on peripheral blood MDSCs, Bregs, and Tregs | baseline, cycle 3 | |
| Describe the programmed death-ligand 1 (PD1) expression profile on peripheral blood MDSCs, Bregs, and Tregs | baseline, cycle 3 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with advanced NSCLC and healthy volunteers with no diagnosis of cancer, known immunodeficiency or other serious chronic illness
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| Name | Affiliation | Role |
|---|---|---|
| Nasser Hanna, MD | Indiana Unversity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin & Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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10 mL of blood will be collected at each time point
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |