NCT05255965

IL-8+ naïve T Cells as a Biomarker for Thymoma Identification

IL-8+ naïve T Cells as a Biomarker for Thymoma Identification: A Prospective, Multi-center Diagnostic Accuracy Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 310 (actual)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

According to the existing literature reports, the misdiagnosis rate of CT is as high as 22% - 68%. Thymic cyst and lymphoma are usually misdiagnosed as thymoma, resulting in many unnecessary operations; In addition, traditional imaging technologies can also cause a missed diagnosis rate of about 7%, which is common in the missed diagnosis of asymptomatic thymoma, which delays the opportunity of treatment. Therefore, in order to accurately treat thymic tumors, the existing diagnostic methods of thymic tumors need to be further optimized. Our previous retrospective study found that the level of IL-8 + initial T cells can well distinguish thymoma from other types of anterior mediastinal tumors, and the sensitivity and specificity are close to 95%.

Detailed description

This study is a prospective, multicenter diagnostic accuracy study. 310 patients with anterior mediastinal space occupying lesions who meet the enrollment conditions are planned to be recruited continuously. 5ml peripheral venous blood of the patients is taken before surgery or puncture biopsy and sent to the laboratory for blind detection of IL-8 + initial T cell level; Then the patient underwent anterior mediastinal tumor surgery or biopsy to obtain pathological results (gold standard for diagnosis). After the pathological results were confirmed, all cases were divided into thymoma group and non thymoma group. The sensitivity and specificity of IL-8 + initial T cells in the diagnosis of thymoma and the cutoff value of thymoma were calculated.

Conditions

• Thymoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	level of IL-8+ initial T cells	5ml peripheral venous blood was taken before surgery or biopsy, and the levels of initial T cell with IL-8+, PLXND1+, PTK7+ or CR2+ were detected and recorded within 6 hours, respectively.

Timeline

• Start date: 2023-05-02
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2022-02-25
• Last updated: 2025-01-16

Locations

1 site across 1 country: China