Thymic Epithelial TumorMTDPUMCHNCT06421805
Establishing Prospective Mediastinal Tumor Database of PUMCH
An observational study of Thymic Epithelial Tumor and Teratoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study aims to prospectively document the population characteristics, imaging findings, pathological features, prognostic factors, etc., of patients with mediastinal tumors. Clinical information will be structured and processed, and it is recommended to establish a mediastinal tumors database at Peking Union… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thymic Epithelial Tumor, Teratoma, Thymic Cyst
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to 30 Dec 2045
- How long will I take part?
- 20 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with mediastinal tumors clinically or pathologically.
Who may be able to join
- Clinical or pathological diagnosis of mediastinal tumors;
- Written consent is able to obtained.
Who cannot join
- 1. Incomplete clinicopathological information.
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xuehan Gao, MD, 18801341299, gaoxh1299@163.com
Yeye Chen, MD, 13671338819, chenyeye@pumch.cn
About this study
Official title: A Single-center, Prospective, and Observational Study on Population Characteristics, Pathological Features, and Prognostic Factors of Patients With Mediastinal Tumor: Establishing Mediastinal Tumor Database of PUMCH.
This study aims to prospectively document the population characteristics, imaging findings, pathological features, prognostic factors, etc., of patients with mediastinal tumors. Clinical information will be structured and processed, and it is recommended to establish a mediastinal tumors database at Peking Union Medical College Hospital. The goal is to provide support for the quality of diagnosis and treatment, clinical protocols, and medical decision-making related to mediastinal tumors.
Read the detailed description
Mediastinal tumors encompass a variety of tumors originating in the mediastinum, comprising both benign and malignant tumors, those invading mediastinal structures during disease progression, or metastases from malignant tumors originating elsewhere in the body. Based on their relationship with the pericardium, mediastinal tumors can be categorized into anterior mediastinal tumors, commonly including thymomas, retrosternal goiters, teratomas, and germ cell tumors; middle mediastinal tumors, which often include bronchogenic cysts, lymphomas, malignant lymphomas, pericardial cysts, lipomas, and esophageal cysts; and posterior mediastinal tumors, where neurogenic tumors and neurofibromas are prevalent. Mediastinal tumors are relatively rare compared to other solid tumors and exhibit complex pathological types. Consequently, conducting prospective randomized controlled clinical trials is challenging, and the significant treatment disparities among different types of mediastinal tumors affect patient survival outcomes. Clinicians often have limited understanding of some complex mediastinal tumors due to the lack of quality and reliable diagnostic and treatment standards or survival data. Therefore, establishing a specialized database for mediastinal tumor research holds great practical significance for the effective development of clinical practice.
Tumor registration databases in North America and Europe have been established earlier, with wide coverage and relatively mature development. For example, the National Cancer Database (NCDB) in the United States is the largest tumor registration database globally, with over 1500 hospitals reporting tumor data to it, covering approximately 70% of newly diagnosed cancer cases. The Surveillance, Epidemiology, and End Results (SEER) database is a public health database based on tumor populations in some states and counties in the United States (17 regional registration centers). It has been registering data since 1973, covering tumor monitoring, epidemiology, and prognosis information. Both databases have high coverage and reasonable registration and verification systems, providing a wealth of high-level evidence for the formulation of tumor prevention and control strategies.
In China, the development in this field started relatively late. To integrate resources, deeply explore data information, and further improve the diagnosis and treatment level and patient management level of mediastinal tumors in China, it is necessary to establish a scientifically standardized specialized mediastinal tumor database.
- Conditions
- Thymic Epithelial Tumor, Teratoma, Thymic Cyst, Retrosternal Goitre, Germ Cell Tumor, Lymphoma
- Keywords
- mediastinal tumors, database, thymic epithelial tumor
- Medical subject headings
- Thymic epithelial tumor, Teratoma, Mediastinal Cyst, Goiter, Substernal, Neoplasms, Germ Cell and Embryonal, Lymphoma, Neurilemmoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| thymoma | mediastinal tumors_thymoma | |
| teratoma | mediastinal tumors_teratomas | |
| germ cell tumor | mediastinal tumors_germ cell tumors | |
| lymphoma | mediastinal tumor_lymphoma | |
| mediastinal neuroendocrine tumors (NETs) | mediastinal tumor_NETs, including neuroendocrine tumours and neuroendocrine carcinomas. | |
| neurinoma | mediastinal tumor_neurinoma | |
| thymic carcinoma | mediastinal tumor_thymic carcinoma | |
| others | mediastinal tumors_other tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall survival of patients with mediastinal tumors
Measured: From date of enrollment until the date of death from any cause, assessed up to 20 years
Secondary outcomes (1)
Progression free survival (PFS)
Progression free survival of patients with mediastinal tumors
Measured: From date of enrollment until the date of first documented progression, assessed up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Jan 2012
- Primary completion30 Dec 2044 (estimated)
- Study completion30 Dec 2045 (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.
- More trials run by Peking Union Medical College 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuehan Gao, Peking Union Medical College Hospital
- Investigators
- Shanqing Li, Prof., Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421805
- Sponsor's protocol ID
- MTDPUMCH
- Acronym
- MTDPUMCH
- Status last verified
- May 2024
- First submitted
- 20 Apr 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research results have not been published.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, and Observational Study on Population Characteristics, Pathological Features, and Prognostic Factors of Patients With Mediastinal Tumor: Establishing Mediastinal Tumor Database of PUMCH.
- ClinicalTrials.gov ID
- NCT06421805
- Acronym / sponsor ID
- MTDPUMCH / MTDPUMCH
- Conditions
- Thymic Epithelial Tumor, Teratoma, Thymic Cyst, Retrosternal Goitre, Germ Cell Tumor, Lymphoma
- Keywords
- mediastinal tumors, database, thymic epithelial tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Dec 2044 (estimated)
- Study completion
- 30 Dec 2045 (estimated)
- First posted
- 20 May 2024 (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.
This study aims to prospectively document the population characteristics, imaging findings, pathological features, prognostic factors, etc., of patients with mediastinal tumors. Clinical information will be structured and processed, and it is recommended to establish a mediastinal tumors database at Peking Union Medical College Hospital. The goal is to provide support for the quality of diagnosis and treatment, clinical protocols, and medical decision-making related to mediastinal tumors.
Detailed description
Mediastinal tumors encompass a variety of tumors originating in the mediastinum, comprising both benign and malignant tumors, those invading mediastinal structures during disease progression, or metastases from malignant tumors originating elsewhere in the body. Based on their relationship with the pericardium, mediastinal tumors can be categorized into anterior mediastinal tumors, commonly including thymomas, retrosternal goiters, teratomas, and germ cell tumors; middle mediastinal tumors, which often include bronchogenic cysts, lymphomas, malignant lymphomas, pericardial cysts, lipomas, and esophageal cysts; and posterior mediastinal tumors, where neurogenic tumors and neurofibromas are prevalent. Mediastinal tumors are relatively rare compared to other solid tumors and exhibit complex pathological types. Consequently, conducting prospective randomized controlled clinical trials is challenging, and the significant treatment disparities among different types of mediastinal tumors affect patient survival outcomes. Clinicians often have limited understanding of some complex mediastinal tumors due to the lack of quality and reliable diagnostic and treatment standards or survival data. Therefore, establishing a specialized database for mediastinal tumor research holds great practical significance for the effective development of clinical practice.
Tumor registration databases in North America and Europe have been established earlier, with wide coverage and relatively mature development. For example, the National Cancer Database (NCDB) in the United States is the largest tumor registration database globally, with over 1500 hospitals reporting tumor data to it, covering approximately 70% of newly diagnosed cancer cases. The Surveillance, Epidemiology, and End Results (SEER) database is a public health database based on tumor populations in some states and counties in the United States (17 regional registration centers). It has been registering data since 1973, covering tumor monitoring, epidemiology, and prognosis information. Both databases have high coverage and reasonable registration and verification systems, providing a wealth of high-level evidence for the formulation of tumor prevention and control strategies.
In China, the development in this field started relatively late. To integrate resources, deeply explore data information, and further improve the diagnosis and treatment level and patient management level of mediastinal tumors in China, it is necessary to establish a scientifically standardized specialized mediastinal tumor database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| thymoma | – | –mediastinal tumors_thymoma |
| teratoma | – | –mediastinal tumors_teratomas |
| germ cell tumor | – | –mediastinal tumors_germ cell tumors |
| lymphoma | – | –mediastinal tumor_lymphoma |
| mediastinal neuroendocrine tumors (NETs) | – | –mediastinal tumor_NETs, including neuroendocrine tumours and neuroendocrine carcinomas. |
| neurinoma | – | –mediastinal tumor_neurinoma |
| thymic carcinoma | – | –mediastinal tumor_thymic carcinoma |
| others | – | –mediastinal tumors_other tumors |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with mediastinal tumors clinically or pathologically.
Key inclusion criteria (2 listed)
- Clinical or pathological diagnosis of mediastinal tumors;
- Written consent is able to obtained.
Key exclusion criteria (1 listed)
- 1. Incomplete clinicopathological information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: From date of enrollment until the date of death from any cause, assessed up to 20 years
Overall survival of patients with mediastinal tumors
1 secondary outcome
Progression free survival (PFS)
Time frame: From date of enrollment until the date of first documented progression, assessed up to 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 20 May 2024.
- Individual participant dataSharing planned: No. The research results have not been published.
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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.
Shanqing Li, Prof. study chair
Peking Union Medical College Hospital
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 Teratoma, run by Peking Union Medical College 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 2 inclusion and 1 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 20 May 2024. 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?
Contact Xuehan Gao, MD (+86 18801341299, gaoxh1299@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From date of enrollment until the date of death from any cause, assessed up to 20 years). 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 20 May 2024.