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

Not Applicable

Completed

• Conditions: NSCLC
• Interventions: Other: Liquid biopsy

• Registration Number: NCT02890849
• Lead Sponsor: Xinqiao Hospital of Chongqing

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-07
• Study Start: 2016-10
• Primary Completion: 2019-06
• Study Completion: 2019-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Pathological histology and/or cytology confirmed malignant tumor;
2. Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.

Exclusion Criteria

1. Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
2. Patients with a history of autoimmune disease;
3. Patients with participating in other clinical trials at the same time;
4. Other cases that researchers believe that patients should not participate in the present trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
a prospective, open, self-controlled phase I clinical study	Liquid biopsy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The match rate of PD-L1 protein expression and PD-L1 mRNA in tumor tissue.	up to one and a half years