Clinical Research for the Consistency Analysis of PD-L1 in Cancer Tissue and Plasma Exosome (RadImm01)

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.

Study Overview

• Status: Completed
• Conditions: NSCLC
• Intervention / Treatment: Other: Liquid biopsy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: a prospective, open, self-controlled phase I clinical study; 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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Correlation between PD-L1 mRNA expression in pExo and immune indexes.	up to one and a half years

Collaborators and Investigators

• Sponsor: Xinqiao Hospital of Chongqing

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimated): September 7, 2016

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: XQonc-004