NCT03073902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

March 25, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
Last Updated

December 28, 2018

Status Verified

December 1, 2018

Enrollment Period

1 year

First QC Date

February 26, 2017

Last Update Submit

December 26, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • The match rate of PD-L1 protein expression in non-small lung cancer tissue and peripheral blood T cell .

    consistency

    up to two years

  • The match rate of PD-L1 protein expression in non-small lung cancer tissue and serum.

    consistency

    up to two years

Study Arms (1)

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

Interventions

Liquid biopsyDIAGNOSTIC_TEST

Liquid biopsy

Observed group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinqiao Hospital of Chongqing

Chongqing, 400000, China

Location

MeSH Terms

Interventions

Liquid Biopsy

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director,Head of Oncology department, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

February 26, 2017

First Posted

March 8, 2017

Study Start

March 25, 2017

Primary Completion

March 31, 2018

Study Completion

December 10, 2018

Last Updated

December 28, 2018

Record last verified: 2018-12

Locations