- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03073902
The Correlation of PD-L1 Expression in Non-small Lung Cancer Tissue and Peripheral Blood T Cell and Serum.
December 26, 2018 updated by: Jianguo Sun, Xinqiao Hospital of Chongqing
Clinical Research for the Correlation of PD-L1 Expression in Non-small Lung Cancer Tissue and Peripheral Blood T Cell and Serum.
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 expression in serum and peripheral blood T cell are expected to be simple, rapid, non-invasive means of detection.
The project is planned to explore the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral blood T cell and serum..The investigators have designed to detected the expression levels of PD-L1 protein in cancer tissue and detected the expression levels of PD-L1 in peripheral blood T cell and serum.By using variance analysis of repeated measures design information.
Thus exploring the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral blood T cell and serum,guiding clinical practice of immunotherapy.
Study Overview
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Chongqing, China, 400000
- Xinqiao Hospital of Chongqing
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pathological histology and/or cytology confirmed non-small lung cancer
Description
Inclusion Criteria:
- Pathological histology and/or cytology confirmed non-small lung cancer;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observed group
The project is planned to explore the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral blood T cell and serum.The investigators have designed to detected the expression levels of PD-L1 protein in cancer tissue and detected the expression levels of PD-L1 in peripheral blood T cell and serum by using variance analysis of repeated measures design information.
|
Liquid biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The match rate of PD-L1 protein expression in non-small lung cancer tissue and peripheral blood T cell .
Time Frame: up to two years
|
consistency
|
up to two years
|
|
The match rate of PD-L1 protein expression in non-small lung cancer tissue and serum.
Time Frame: up to two years
|
consistency
|
up to two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 25, 2017
Primary Completion (Actual)
March 31, 2018
Study Completion (Actual)
December 10, 2018
Study Registration Dates
First Submitted
February 26, 2017
First Submitted That Met QC Criteria
March 2, 2017
First Posted (Actual)
March 8, 2017
Study Record Updates
Last Update Posted (Actual)
December 28, 2018
Last Update Submitted That Met QC Criteria
December 26, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- XQonc-006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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