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

NSCLC Clinical Trial

— RadImm01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890849
• Other study ID #: XQonc-004
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 2019

Study information

• Verified date: February 2024
• Source: Xinqiao Hospital of Chongqing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• NSCLC

Intervention

Other:
• Liquid biopsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between PD-L1 mRNA expression in pExo and immune indexes.		up to one and a half years
Primary	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	The match rate of PD-L1 protein expression and PD-L1 mRNA in tumor tissue.		up to one and a half years