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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05255965
Enrollment
310
Registered
2022-02-25
Start date
2023-05-02
Completion date
2024-10-31
Last updated
2025-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thymoma

Keywords

thymoma

Brief 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.

Interventions

DIAGNOSTIC_TESTlevel 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.

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The specificity of levels of IL-8+ initial T cells in the diagnosis of thymomaThrough study completion, an average of 2 year
The cutoff value of levels of IL-8+ initial T cells in the diagnosis of thymomaThrough study completion, an average of 2 year
The sensitivity of levels of IL-8+ initial T cells in the diagnosis of thymomaThrough study completion, an average of 2 year

Secondary

MeasureTime frame
The specificity of levels of PTK7+ initial T cells in the diagnosis of thymomaThrough study completion, an average of 2 year
The sensitivity of levels of CR2+ initial T cells in the diagnosis of thymomaThrough study completion, an average of 2 year
The specificity of levels of CR2+ initial T cells in the diagnosis of thymomaThrough study completion, an average of 2 year
The sensitivity of levels of PLXND1+ initial T cells in the diagnosis of thymomaThrough study completion, an average of 2 year
The specificity of enhanced CT/MRI in the diagnosis of thymomaThrough study completion, an average of 2 year
The sensitivity of levels of IL-8+, PLXND1+, PTK7+ and/or CR2+ initial T cells combined with enhanced CT/MRI in the diagnosis of thymomaThrough study completion, an average of 2 year
The sensitivity of enhanced CT/MRI in the diagnosis of thymomaThrough study completion, an average of 2 year
The specificity of levels of PLXND1+ initial T cells in the diagnosis of thymomaThrough study completion, an average of 2 year
The sensitivity of levels of PTK7+ initial T cells in the diagnosis of thymomaThrough study completion, an average of 2 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026