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This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer, immunotherapy naive participants can predict the effectiveness of immunotherapy treatment as well as determine ahead of time adverse events and their severity. In addition, the investigator will look into microbiome changing modifiers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunotherapy naïve NSCLC patients | Microbiome in immunotherapy naïve NSCLC patients receiving PD-1/L1 blockade |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microbiome | Diagnostic Test | Nasal and buccal swabs, and stool sample, as well as the extracted DNAs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome difference between patients with and without AEs>=grade 3 | Adverse events (AEs) will be graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome difference between responders vs. nonresponders | Treatment response will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 | Through study completion, an average of 1 year |
| Correlation of microbiome to tumor tissue PD-L1 expression |
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Inclusion Criteria:
Exclusion Criteria:
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Immunotherapy naïve metastatic/advanced/recurrent NSCLC patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KUCC Navigation | Contact | 9135883671 | kucc_Navigation@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang, MD, PhD | The University of Kansas Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Cancer Center (KUCC) | Recruiting | Fairway | Kansas | 66205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29781826 | Background | Swami U, Zakharia Y, Zhang J. Understanding Microbiome Effect on Immune Checkpoint Inhibition in Lung Cancer: Placing the Puzzle Pieces Together. J Immunother. 2018 Oct;41(8):359-360. doi: 10.1097/CJI.0000000000000232. | |
| 30183502 | Background | Strouse C, Mangalam A, Zhang J. Bugs in the system: bringing the human microbiome to bear in cancer immunotherapy. Gut Microbes. 2019;10(2):109-112. doi: 10.1080/19490976.2018.1511665. Epub 2018 Sep 5. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D064307 | Microbiota |
| ID | Term |
|---|---|
| D008827 | Microbiological Phenomena |
| D058448 | Biota |
| D044822 | Biodiversity |
| D017753 | Ecosystem |
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Nasal and buccal swabs, and stool sample, as well as the extracted DNAs for current and future, study-related research
PD-L1 expression is per standard of care using IHC |
| Through study completion, an average of 1 year |
| Correlation of microbiome to diet | Customized Diet Survey | Through study completion, an average of 1 year |
| The University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
| The University of Kansas Cancer Center, Westwood Campus | Recruiting | Kansas City | Kansas | 66205 | United States |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004777 |
| Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |