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临床试验/NCT06421805
NCT06421805招募中不适用

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.

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
1
主要终点
Overall survival (OS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • Incomplete clinicopathological information.

结局指标

主要结局

Overall survival (OS)

时间窗: From date of enrollment until the date of death from any cause, assessed up to 20 years

Overall survival of patients with mediastinal tumors

次要结局

  • Progression free survival (PFS)(From date of enrollment until the date of first documented progression, assessed up to 20 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xuehan Gao

Principal Investigator

Peking Union Medical College Hospital

研究点 (1)

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