Establishing Prospective Mediastinal Tumor Database of PUMCH (MTDPUMCH)

May 14, 2024 updated by: Xuehan Gao, Peking Union Medical College Hospital

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xuehan Chen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with mediastinal tumors clinically or pathologically.

Description

Inclusion Criteria:

  1. Clinical or pathological diagnosis of mediastinal tumors;
  2. Written consent is able to obtained.

Exclusion Criteria:

1. Incomplete clinicopathological information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of enrollment until the date of death from any cause, assessed up to 20 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: From date of enrollment until the date of first documented progression, assessed up to 20 years
Progression free survival of patients with mediastinal tumors
From date of enrollment until the date of first documented progression, assessed up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Shanqing Li, Prof., Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Estimated)

December 30, 2044

Study Completion (Estimated)

December 30, 2045

Study Registration Dates

First Submitted

April 20, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTDPUMCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The research results have not been published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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