Exosomal PD-L1 Level in plasma as a predictive marker for diagnosis and clinical correlation in non-small cell lung cancer

Recruiting

• Conditions: on small cell lung cancer; Biomarker; Exosome; liquid biopsy; pathology; PD-L; Non-small cell lung cancer

• Registration Number: TCTR20210808001
• Lead Sponsor: Chulalongkorn University Systems biology center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-08
• Study Completion: 2022-07-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Aged 18 years or older
2.Body weight > 30 kg
3.NSCLC patients with confirmed diagnosis by tissue biopsy
4.Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
5.Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1

Exclusion Criteria

1.Pregnant and lactating women
2.Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder or superior vena cava syndrome)
3.Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomisation, unstable arrhythmias or unstable angina
i.Patients with a known left ventricular ejection fraction (LVEF) < 40% will be excluded
4.Severe infections within 4 weeks after receiving treatment including but not limited to hospitalisation for complications of infection, bacteraemia or severe pneumonia
5.Known active or untreated central nervous system (CNS) metastases
6.Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression-free survival at which tumors recurrence is detected time scale

Secondary Outcome Measures

Name	Time	Method
correlation between exosomal PD-L1 and tumor PD-L1 Before resection of tumor percentage of expression and levels of exosomal PD-L1,dynamic of exosomal PD-L1 change before and after resection of tumor ELISA,difference of the level of exosomal PD-L1 levels between each stage of non-small cell lung cancer before resection of tumor ELISA,correlation between clinical variables and exosomal PD-L1 before resection of tumor ELISA