ThymomaNCT05255965
IL-8+ naïve T Cells as a Biomarker for Thymoma Identification
An observational study of Thymoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thymoma
- What is being tested?
- level of IL-8+ initial T cells
- How many people
- 310 participants
- Where
- 1 siteChina
- Study dates
- 2 May 2023to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients who are clinically diagnosed with thymic masses.
Who may be able to join
- 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.
Who cannot join
- Adolescents and children under the age of 18;
- The patient's anterior mediastinal mass can not be diagnosed by biopsy or surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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%.
Read the 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.
- Conditions
- Thymoma
- Being tested
- level of IL-8+ initial T cells
- Keywords
- thymoma
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
level of IL-8+ initial T cellsDiagnostic test
Also called level of PLXND1+ initial T cells, level of PTK7+ initial T cells, level of CR2+ 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of levels of IL-8+ initial T cells in the diagnosis of thymoma
Measured: Through study completion, an average of 2 year
The specificity of levels of IL-8+ initial T cells in the diagnosis of thymoma
Measured: Through study completion, an average of 2 year
The cutoff value of levels of IL-8+ initial T cells in the diagnosis of thymoma
Measured: 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
Measured: Through study completion, an average of 2 year
The specificity of levels of PLXND1+ initial T cells in the diagnosis of thymoma
Measured: Through study completion, an average of 2 year
The sensitivity of levels of PTK7+ initial T cells in the diagnosis of thymoma
Measured: Through study completion, an average of 2 year
The specificity of levels of PTK7+ initial T cells in the diagnosis of thymoma
Measured: Through study completion, an average of 2 year
The sensitivity of levels of CR2+ initial T cells in the diagnosis of thymoma
Measured: Through study completion, an average of 2 year
The specificity of levels of CR2+ initial T cells in the diagnosis of thymoma
Measured: Through study completion, an average of 2 year
The sensitivity of enhanced CT/MRI in the diagnosis of thymoma
Measured: Through study completion, an average of 2 year
The specificity of enhanced CT/MRI in the diagnosis of thymoma
Measured: 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
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start2 May 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThymomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianyong Ding, Study chair, Zhongshan Hospital Attached To Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255965
- Sponsor's protocol ID
- B2021-812
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2022
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IL-8+ naïve T Cells as a Biomarker for Thymoma Identification: A Prospective, Multi-center Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT05255965
- Acronym / sponsor ID
- B2021-812
- Conditions
- Thymoma
- Keywords
- thymoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients who are clinically diagnosed with thymic masses.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Adolescents and children under the age of 18;
- The patient's anterior mediastinal mass can not be diagnosed by biopsy or surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| level of IL-8+ initial T cellsAlso: level of PLXND1+ initial T cells, level of PTK7+ initial T cells, level of CR2+ initial T cells5ml 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. | Diagnostic test | – |
Primary outcome
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
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
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
9 secondary outcomes
The sensitivity of levels of PLXND1+ initial T cells in the diagnosis of thymoma
Time frame: Through study completion, an average of 2 year
The specificity of levels of PLXND1+ initial T cells in the diagnosis of thymoma
Time frame: Through study completion, an average of 2 year
The sensitivity of levels of PTK7+ initial T cells in the diagnosis of thymoma
Time frame: Through study completion, an average of 2 year
The specificity of levels of PTK7+ initial T cells in the diagnosis of thymoma
Time frame: Through study completion, an average of 2 year
The sensitivity of levels of CR2+ initial T cells in the diagnosis of thymoma
Time frame: Through study completion, an average of 2 year
The specificity of levels of CR2+ initial T cells in the diagnosis of thymoma
Time frame: Through study completion, an average of 2 year
The sensitivity of enhanced CT/MRI in the diagnosis of thymoma
Time frame: Through study completion, an average of 2 year
The specificity of enhanced CT/MRI in the diagnosis of thymoma
Time frame: 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
Time frame: Through study completion, an average of 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianyong Ding study chair
Zhongshan Hospital Attached To Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thymoma, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.