An observational study in Lung Neoplasm, Squamous Cell Carcinoma and Exosomes, sponsored by Tianjin Medical University Cancer Institute and Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Observational
This is an observational prospective bi-center study of 50 patients operated on advanced squamous cell carcinoma. The main aim is to investigate the efficacy of serum exosomal miRNA as a biomarker for predicting the therapeutic effect of immunotherapy combined with chemotherapy.
PD-L1 Testing in guiding patient selection for PD-1/PD-L1 inhibitor therapy in Lung Cancer exhibits insufficient sensitivity and efficacy. The investigators aimed to identify specific serum exosomal miRNA biomarkers that are highly sensitive and stable for predicting the therapeutic effect of immunotherapy combined with chemotherapy. So that the clinicians could use the biomarker to better stratify patients and select potential immunotherapy-beneficial subgroups before clinical decisions.
We plan to enroll 50 patients with advanced treatment-naïve squamous cell carcinoma and 10 healthy people in the present study. Peripheral blood from the plasma of 10 healthy individuals and 50 pulmonary squamous cell carcinoma (SCC) patients will be collected before first-line treatment and after 2 cycles of anti-PD-L1 immunotherapy combined with chemotherapy.
Firstly, exosomal miRNAs extracted from peripheral blood will be analyzed through high-throughput RNA sequencing to identify specific exosomal miRNAs.
Secondly, through analyzing the PFS and OS follow-up data of patients, they are divided into different subgroups. We explore the value of early predicting efficacy of exosome miRNA basing on sequencing results.
Thirdly, we compared the exo-miRNA biomarker with the value of PD-L1 expression in predicting the efficacy of immunotherapy.
Lastly, we suggest exo-miRNA combined with PD-L1 as a biomarker combination in predicting anti-PD-L1 immunotherapy efficacy to better select the potential benefit population suitable for immunotherapy.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 60 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.
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Patients diagnosed as advanced lung squamous carcinoma by histopathology and be treated with anti-PD-L1 combined with chemotherapy
Exclusion Criteria:
advanced pulmonary carcinoma with pathological diagnosis of squamous cell and are applied with first line treatment of anti-PD-L1 combined with chemotherapy
Diagnostic Test: collect plasma samples and clinical features
10 normol volunteers will be enrolled in the group
Diagnostic Test: collect plasma samples and clinical features
8ml of peripheral blood need to be collected from pre- and post-treatment advanced pulmonary squamous carcinoma separately
plasma exosomal miRNA level
The expression levels of serum exosome micro RNA
Time frame: Baseline up to 21 days
PD-L1
the expression levels of PD-L1
Time frame: Baseline up to 21 days
Imaging data of lesions
Imaging data of the pulmonary and metastatic lesions of the patients are collected
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Objective response rate
Time frame: From the start of systemic treatment date until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 100 months
Plan to share: No
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University Cancer Institute and Hospital