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

NCT02890849 | Completed

• 1 other identifier: XQonc-004
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The match rate of PD-L1 protein expression and PD-L1 mRNA in tumor tissue.

  up to one and a half years

Other Outcomes (1)

• Correlation between PD-L1 mRNA expression in pExo and immune indexes.

  up to one and a half years

Study Arms (1)

a prospective, open, self-controlled phase I clinical study

EXPERIMENTAL

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

Interventions

Liquid biopsy OTHER

a prospective, open, self-controlled phase I clinical study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

MeSH Terms

Interventions

Liquid Biopsy

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 7, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 23, 2024

Record last verified: 2024-02