The Correlation of PD-L1 Expression in Non-small Lung Cancer Tissue and Peripheral Blood T Cell and Serum.

• Sponsor: Xinqiao Hospital of Chongqing (Other)
• Overall Status: Completed
• CT.gov ID: NCT03073902
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 20.5
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
NSCLC	Diagnostic Test: Liquid biopsy

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Research for the Correlation of PD-L1 Expression in Non-small Lung Cancer Tissue and Peripheral Blood T Cell and Serum.
• Actual Study Start Date: Mar 25, 2017
• Actual Primary Completion Date: Mar 31, 2018
• Actual Study Completion Date: Dec 10, 2018

Arms and Interventions

Arm

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.

Diagnostic Test: Liquid biopsy; Liquid biopsy

Outcome Measures

Primary Outcome Measures

1. The match rate of PD-L1 protein expression in non-small lung cancer tissue and peripheral blood T cell . [up to two years]

   consistency

2. The match rate of PD-L1 protein expression in non-small lung cancer tissue and serum. [up to two years]

   consistency

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Pathological histology and/or cytology confirmed non-small lung cancer;

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xinqiao Hospital of Chongqing	Chongqing		China	400000

Sponsors and Collaborators

• Xinqiao Hospital of Chongqing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jianguo Sun, Deputy Director,Head of Oncology department, Principal Investigator, Clinical Professor, Xinqiao Hospital of Chongqing
• ClinicalTrials.gov Identifier: NCT03073902
• Other Study ID Numbers: XQonc-006
• First Posted: Mar 8, 2017
• Last Update Posted: Dec 28, 2018
• Last Verified: Dec 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 28, 2018