Thymic Epithelial TumorNCT05667948
Molecular Analysis and Treatment Options of Thymic Malignancies
An observational study of Thymic Epithelial Tumor and Thymic Carcinoma, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
Thymic malignancies are the most common tumors of the anterior mediastinum, though surgery and radiation often effectively treat thymic carcinomas, a minority continue to progress and eventually lead to death. Therefore, there is an unmet need for more effective therapies for thymic malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thymic Epithelial Tumor, Thymic Carcinoma, Thymic Cancer
- What is being tested?
- Chemotherapy
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Participants with thymic malignancies are with the standard treatment and/or are enrolled in the clinical trials.
Who may be able to join
- Histologically proven diagnosis of thymic malignancies
- 18 years of age or older
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiaomin Niu
Shanghai, Shanghai Municipality, 200030
Xiaomin Niu, 021-22200000, ar_tey@hotmail.com
About this study
Official title: Molecular Landscape Analysis and Treatment Options for Thymic Epithelial Tumors
Thymic malignancies are the most common tumors of the anterior mediastinum, though surgery and radiation often effectively treat thymic carcinomas, a minority continue to progress and eventually lead to death. Therefore, there is an unmet need for more effective therapies for thymic malignancies. Considering the role of molecular alterations has yet to be defined in the treatment of thymoma and thymic malignancies, there is an urgent recognition that molecular alterations in the thymic malignancies are important to predict response and survival for novel targeted therapies.
In summary, identification of genetic alterations in thymic malignancies is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with thymic malignancies to further the characterization of molecular alterations and develop (novel) treatments based on the detection.
- Conditions
- Thymic Epithelial Tumor, Thymic Carcinoma, Thymic Cancer
- Being tested
- Chemotherapy
- Keywords
- thymic malignancy, thymoma, chemotherapy, targeted therapy, immunotherapy, molecular landscape
- Medical subject headings
- Thymic epithelial tumor, Thymoma, Thymus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called targeted therapy, immunotherapy
different treatments based on the molecular analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Collect detailed clinical information on patients with thymic malignancies via the electronic medical records
Measured: 20 years
Disease control rate (DCR)
Collect detailed clinical information on patients with thymic malignancies via the electronic medical records
Measured: 20 years
Progression-free survival (PFS)
Collect detailed clinical information on patients with thymic malignancies via the electronic medical records
Measured: 20 years
Secondary outcomes (1)
Overall survival (OS)
Collect detailed clinical information on patients with thymic malignancies via the electronic medical records
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start1 Jan 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymic Epithelial TumorStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaomin Niu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667948
- Sponsor's protocol ID
- THORACIC002
- Status last verified
- May 2025
- First submitted
- 30 Nov 2022
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Landscape Analysis and Treatment Options for Thymic Epithelial Tumors
- ClinicalTrials.gov ID
- NCT05667948
- Acronym / sponsor ID
- THORACIC002
- Conditions
- Thymic Epithelial Tumor, Thymic Carcinoma, Thymic Cancer
- Keywords
- thymic malignancy, thymoma, chemotherapy, targeted therapy, immunotherapy, molecular landscape
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Dec 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.
Thymic malignancies are the most common tumors of the anterior mediastinum, though surgery and radiation often effectively treat thymic carcinomas, a minority continue to progress and eventually lead to death. Therefore, there is an unmet need for more effective therapies for thymic malignancies. Considering the role of molecular alterations has yet to be defined in the treatment of thymoma and thymic malignancies, there is an urgent recognition that molecular alterations in the thymic malignancies are important to predict response and survival for novel targeted therapies.
In summary, identification of genetic alterations in thymic malignancies is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with thymic malignancies to further the characterization of molecular alterations and develop (novel) treatments based on the detection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with thymic malignancies are with the standard treatment and/or are enrolled in the clinical trials.
Key inclusion criteria (3 listed)
- Histologically proven diagnosis of thymic malignancies
- 18 years of age or older
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ChemotherapyAlso: targeted therapy, immunotherapydifferent treatments based on the molecular analysis | Drug | – |
Primary outcome
Objective response rate (ORR)
Time frame: 20 years
Collect detailed clinical information on patients with thymic malignancies via the electronic medical records
Disease control rate (DCR)
Time frame: 20 years
Collect detailed clinical information on patients with thymic malignancies via the electronic medical records
Progression-free survival (PFS)
Time frame: 20 years
Collect detailed clinical information on patients with thymic malignancies via the electronic medical records
1 secondary outcome
Overall survival (OS)
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Thymic Epithelial Tumor and Thymic Carcinoma, run by Shanghai Chest 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 0 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: looking for participants now, as of the sponsor's last update on 22 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 20 years). 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 22 May 2025.