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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02890849

Acronym

RadImm01

Enrollment

Registered

2016-09-07

Start date

2016-10-31

Completion date

2019-08-31

Last updated

2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

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.

Interventions

OTHERLiquid biopsy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026