Clinical Research for the Consistency Analysis of PD-L1 in Cancer Tissue and Plasma Exosome

Study Overview
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Brief Summary
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The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has an important role in guiding for the treatment of immune detection point. At the same time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the consistency analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the expression levels of PD-L1 mRNA in pExo.By using variance analysis of repeated measures design information. Thus exploring the consistency analysis of PD-L1 expression level detected in tissues and pExo,guiding clinical practice of radiotherapy combining with immunotherapy.

Official Title
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Clinical Research for the Consistency Analysis of PD-L1 in Cancer Tissue and Plasma Exosome

Conditions
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NSCLC

Intervention / Treatment
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* Other: Liquid biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological histology and/or cytology confirmed malignant tumor; Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent. Exclusion Criteria: Vital organs (e.g., heart, liver, kidney) have serious dysfunction; Patients with a history of autoimmune disease; Patients with participating in other clinical trials at the same time; Other cases that researchers believe that patients should not participate in the present trial.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a prospective, open, self-controlled phase I clinical study<br>The project is planned to explore the consistency analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the expression levels of PD-L1 mRNA in pExo.by using variance analysis of repeated measures design information. | Other: Liquid biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The match rate of PD-L1 protein expression in cancer tissue and PD-L1 mRNA expression in pExo. |  | up to one and a half years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The match rate of PD-L1 protein expression and PD-L1 mRNA in tumor tissue. |  | up to one and a half years |