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

NCT ID: NCT02890849

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-08-31

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.

Conditions

NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Liquid biopsy

Intervention Type: OTHER

Interventions

Liquid biopsy

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role: lead

Responsible Party

Jianguo Sun

Deputy Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

XQonc-004

Identifier Type: -

Identifier Source: org_study_id