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OpenTrials
Completed

NCT Number: NCT02890849

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

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.

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Key information

Conditions

NSCLC

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Liquid Biopsy

Other

Primary outcomes

  1. The match rate of PD-L1 protein expression in cancer tissue and PD-L1 mRNA expression in pExo.

    Time frame: 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.

    Time frame: up to one and a half years

Other outcomes

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

    Time frame: up to one and a half years

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Registry information

Acronym: RadImm01

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2016
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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