Clinical trial NCT05255965: IL-8+ naïve T Cells as a Biomarker for Thymoma Identification
Official title: IL-8+ naïve T Cells as a Biomarker for Thymoma Identification: A Prospective, Multi-center Diagnostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thymoma
Keywords: thymoma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients who are clinically diagnosed with thymic masses.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The sensitivity of levels of IL-8+ initial T cells in the diagnosis of thymoma
timeFrame: Through study completion, an average of 2 year
measure: The specificity of levels of IL-8+ initial T cells in the diagnosis of thymoma
timeFrame: Through study completion, an average of 2 year
measure: The cutoff value of levels of IL-8+ initial T cells in the diagnosis of thymoma
timeFrame: Through study completion, an average of 2 year
Secondary outcomes:
measure: The sensitivity of levels of PLXND1+ initial T cells in the diagnosis of thymoma
timeFrame: Through study completion, an average of 2 year
measure: The specificity of levels of PLXND1+ initial T cells in the diagnosis of thymoma
timeFrame: Through study completion, an average of 2 year
measure: The sensitivity of levels of PTK7+ initial T cells in the diagnosis of thymoma
timeFrame: Through study completion, an average of 2 year
measure: The specificity of levels of PTK7+ initial T cells in the diagnosis of thymoma
timeFrame: Through study completion, an average of 2 year
measure: The sensitivity of levels of CR2+ initial T cells in the diagnosis of thymoma
timeFrame: Through study completion, an average of 2 year
measure: The specificity of levels of CR2+ initial T cells in the diagnosis of thymoma
timeFrame: Through study completion, an average of 2 year
measure: The sensitivity of enhanced CT/MRI in the diagnosis of thymoma
timeFrame: Through study completion, an average of 2 year
measure: The specificity of enhanced CT/MRI in the diagnosis of thymoma
timeFrame: Through study completion, an average of 2 year
measure: 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
timeFrame: Through study completion, an average of 2 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
affiliation: Zhongshan Hospital Attached To Fudan University
name: Jianyong Ding
role: STUDY_CHAIR
References: