NCT05255965

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 2, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

January 16, 2025

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

February 12, 2022

Last Update Submit

January 14, 2025

Conditions

Thymoma

Keywords

thymoma

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Interventions

level of IL-8+ initial T cellsDIAGNOSTIC_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.

Also known as: level of PLXND1+ initial T cells, level of PTK7+ initial T cells, level of CR2+ initial T cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the patients who are clinically diagnosed with thymic masses.

You may qualify if:

  • 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.

You may not qualify if:

  • Adolescents and children under the age of 18;
  • The patient's anterior mediastinal mass can not be diagnosed by biopsy or surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Thymoma

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsThymus NeoplasmsThoracic NeoplasmsNeoplasms by SiteLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jianyong Ding

    Zhongshan Hospital Attached To Fudan University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2022

First Posted

February 25, 2022

Study Start

May 2, 2023

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

January 16, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)