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NCT Number: NCT05255965

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

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%.

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Key information

Conditions

Thymoma Hemic and Lymphatic Diseases Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Thoracic Neoplasms Thymus Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

180 Fenglin Road

Shanghai, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

level of IL-8+ initial T cells

Diagnostic Test

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.

Other names: level of PLXND1+ initial T cells, level of PTK7+ initial T cells, level of CR2+ initial T cells

Primary outcomes

  1. The sensitivity of levels of IL-8+ initial T cells in the diagnosis of thymoma

    Time frame: Through study completion, an average of 2 year

  2. The specificity of levels of IL-8+ initial T cells in the diagnosis of thymoma

    Time frame: Through study completion, an average of 2 year

  3. The cutoff value of levels of IL-8+ initial T cells in the diagnosis of thymoma

    Time frame: Through study completion, an average of 2 year

Secondary outcomes

  1. The sensitivity of levels of PLXND1+ initial T cells in the diagnosis of thymoma

    Time frame: Through study completion, an average of 2 year

  2. The specificity of levels of PLXND1+ initial T cells in the diagnosis of thymoma

    Time frame: Through study completion, an average of 2 year

  3. The sensitivity of levels of PTK7+ initial T cells in the diagnosis of thymoma

    Time frame: Through study completion, an average of 2 year

  4. The specificity of levels of PTK7+ initial T cells in the diagnosis of thymoma

    Time frame: Through study completion, an average of 2 year

  5. The sensitivity of levels of CR2+ initial T cells in the diagnosis of thymoma

    Time frame: Through study completion, an average of 2 year

  6. The specificity of levels of CR2+ initial T cells in the diagnosis of thymoma

    Time frame: Through study completion, an average of 2 year

  7. The sensitivity of enhanced CT/MRI in the diagnosis of thymoma

    Time frame: Through study completion, an average of 2 year

  8. The specificity of enhanced CT/MRI in the diagnosis of thymoma

    Time frame: Through study completion, an average of 2 year

  9. 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

    Time frame: Through study completion, an average of 2 year

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 25, 2022
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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