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

Thymoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255965
• Other study ID #: B2021-812
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Shanghai Zhongshan Hospital
• Contact: Jianyong Ding, M.D.
• Phone: +862164041990
• Email: ding.jianyong[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult, aged 18 and above;

• Patients with anterior mediastinal mass on imaging (chest CT or MRI);

• The patient's anterior mediastinal mass can be diagnosed by biopsy or surgery.

Exclusion Criteria:

• Adolescents and children under the age of 18;

• The patient's anterior mediastinal mass can not be diagnosed by biopsy or surgery.

Related Conditions & MeSH terms

• Thymoma
• Thymus Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity of levels of IL-8+ initial T cells in the diagnosis of thymoma		Through study completion, an average of 2 year
Primary	The specificity of levels of IL-8+ initial T cells in the diagnosis of thymoma		Through study completion, an average of 2 year
Primary	The cutoff value of levels of IL-8+ initial T cells in the diagnosis of thymoma		Through study completion, an average of 2 year
Secondary	The sensitivity of levels of PLXND1+ initial T cells in the diagnosis of thymoma		Through study completion, an average of 2 year
Secondary	The specificity of levels of PLXND1+ initial T cells in the diagnosis of thymoma		Through study completion, an average of 2 year
Secondary	The sensitivity of levels of PTK7+ initial T cells in the diagnosis of thymoma		Through study completion, an average of 2 year
Secondary	The specificity of levels of PTK7+ initial T cells in the diagnosis of thymoma		Through study completion, an average of 2 year
Secondary	The sensitivity of levels of CR2+ initial T cells in the diagnosis of thymoma		Through study completion, an average of 2 year
Secondary	The specificity of levels of CR2+ initial T cells in the diagnosis of thymoma		Through study completion, an average of 2 year
Secondary	The sensitivity of enhanced CT/MRI in the diagnosis of thymoma		Through study completion, an average of 2 year
Secondary	The specificity of enhanced CT/MRI in the diagnosis of thymoma		Through study completion, an average of 2 year
Secondary	The sensitivity of levels of IL-8+, PLXND1+, PTK7+ and/or CR2+ initial T cells combined with enhanced CT/MRI in the diagnosis of thymoma		Through study completion, an average of 2 year