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

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%.

Study Overview

• Status: Recruiting
• Conditions: Thymoma
• Intervention / Treatment: Diagnostic test: level of IL-8+ initial T cells

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.

• Study Type: Observational
• Enrollment (Estimated): 310

Contacts and Locations

• Study Contact: Name: Jianyong Ding, M.D.; Phone Number: +862164041990; Email: ding.jianyong@zs-hospital.sh.cn
• Study Contact Backup: Name: Jiahao Jiang, M.D.; Phone Number: +8615801809430; Email: jiang.jiahao@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • 180 Fenglin Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

the patients who are clinically diagnosed with thymic masses.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The sensitivity of levels of IL-8+ initial T cells in the diagnosis of thymoma	Through study completion, an average of 2 year
The specificity of levels of IL-8+ initial T cells in the diagnosis of thymoma	Through study completion, an average of 2 year
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 Outcome Measures

Outcome Measure	Time Frame
The sensitivity of levels of PLXND1+ initial T cells in the diagnosis of thymoma	Through study completion, an average of 2 year
The specificity of levels of PLXND1+ initial T cells in the diagnosis of thymoma	Through study completion, an average of 2 year
The sensitivity of levels of PTK7+ initial T cells in the diagnosis of thymoma	Through study completion, an average of 2 year
The specificity of levels of PTK7+ initial T cells in the diagnosis of thymoma	Through study completion, an average of 2 year
The sensitivity of levels of CR2+ initial T cells in the diagnosis of thymoma	Through study completion, an average of 2 year
The specificity of levels of CR2+ initial T cells in the diagnosis of thymoma	Through study completion, an average of 2 year
The sensitivity of enhanced CT/MRI in the diagnosis of thymoma	Through study completion, an average of 2 year
The specificity of enhanced CT/MRI in the diagnosis of thymoma	Through 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 thymoma	Through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Jianyong Ding, Zhongshan Hospital Attached To Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 12, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: thymoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Thoracic Neoplasms; Neoplasms, Complex and Mixed; Thymoma; Thymus Neoplasms
• Other Study ID Numbers: B2021-812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No