## Protocol Section
### Identification Module
**NCT ID:** NCT06421805

**Acronym:** MTDPUMCH

**Brief Title:** Establishing Prospective Mediastinal Tumor Database of PUMCH

**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.

#### Organization Study ID Info
**ID:** MTDPUMCH
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
### Status Module
#### Completion Date
**Date:** 2045-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2044-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2012-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-20
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking Union Medical College Hospital

#### Responsible Party

**Investigator Affiliation:** Peking Union Medical College Hospital

**Investigator Full Name:** Xuehan Gao

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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 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.

### Conditions Module

**Conditions:**

- Thymic Epithelial Tumor

- Teratoma

- Thymic Cyst

- Retrosternal Goitre

- Germ Cell Tumor

- Lymphoma

- Schwannoma

**Keywords:**

- mediastinal tumors

- database

- thymic epithelial tumor

### Design Module

#### Bio Spec

**Description:** After obtaining informed consent from the patients, tumor tissue specimens will be stored in the sample repository of PUMCH at -80 degrees Celsius.

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 2000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 20 Years

### Arms Interventions Module

#### Arm Group 1

**Description:** mediastinal tumors_thymoma

**Label:** thymoma

#### Arm Group 2

**Description:** mediastinal tumors_teratomas

**Label:** teratoma

#### Arm Group 3

**Description:** mediastinal tumors_germ cell tumors

**Label:** germ cell tumor

#### Arm Group 4

**Description:** mediastinal tumor_lymphoma

**Label:** lymphoma

#### Arm Group 5

**Description:** mediastinal tumor_NETs, including neuroendocrine tumours and neuroendocrine carcinomas.

**Label:** mediastinal neuroendocrine tumors (NETs)

#### Arm Group 6

**Description:** mediastinal tumor_neurinoma

**Label:** neurinoma

#### Arm Group 7

**Description:** mediastinal tumor_thymic carcinoma

**Label:** thymic carcinoma

#### Arm Group 8

**Description:** mediastinal tumors_other tumors

**Label:** others

### Outcomes Module

#### Primary Outcomes

**Description:** Overall survival of patients with mediastinal tumors

**Measure:** Overall survival (OS)

**Time Frame:** From date of enrollment until the date of death from any cause, assessed up to 20 years

#### Secondary Outcomes

**Description:** Progression free survival of patients with mediastinal tumors

**Measure:** Progression free survival (PFS)

**Time Frame:** From date of enrollment until the date of first documented progression, assessed up to 20 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

1. Incomplete clinicopathological information.

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Patients diagnosed with mediastinal tumors clinically or pathologically.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** gaoxh1299@163.com

**Name:** Xuehan Gao, MD

**Phone:** +86 18801341299

**Role:** CONTACT

**Contact 2:**

**Email:** chenyeye@pumch.cn

**Name:** Yeye Chen, MD

**Phone:** 13671338819

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** gaoxh1299@163.com

- **Name:** Xuehan Gao, MD

- **Phone:** 18801341299

- **Role:** CONTACT

***Contact 2:***

- **Email:** chenyeye@pumch.cn

- **Name:** Yeye Chen, MD

- **Phone:** 13671338819

- **Role:** CONTACT

***Contact 3:***

- **Name:** Xuehan Chen, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Peking Union Medical College Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100730

#### Overall Officials

**Official 1:**

**Affiliation:** Peking Union Medical College Hospital

**Name:** Shanqing Li, Prof.

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Description:** The research results have not been published.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009373

- Term: Neoplasms, Germ Cell and Embryonal

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000018358

- Term: Neuroendocrine Tumors

- ID: D000017599

- Term: Neuroectodermal Tumors

- ID: D000009463

- Term: Neuroma

- ID: D000018317

- Term: Nerve Sheath Neoplasms

- ID: D000009380

- Term: Neoplasms, Nerve Tissue

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000008477

- Term: Mediastinal Diseases

- ID: D000013896

- Term: Thoracic Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000003560

- Term: Cysts

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11220

- Name: Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: M16494

- Name: Teratoma

- Relevance: HIGH

- As Found: Teratoma

- ID: M12386

- Name: Neurilemmoma

- Relevance: HIGH

- As Found: Schwannoma

- ID: M11462

- Name: Mediastinal Neoplasms

- Relevance: HIGH

- As Found: Mediastinal Tumor

- ID: M9147

- Name: Goiter

- Relevance: LOW

- As Found: Unknown

- ID: M6765

- Name: Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M11459

- Name: Mediastinal Cyst

- Relevance: HIGH

- As Found: Thymic Cyst

- ID: M12318

- Name: Neoplasms, Germ Cell and Embryonal

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M20495

- Name: Neuroendocrine Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M19845

- Name: Neuroectodermal Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M20388

- Name: Neuroectodermal Tumors, Primitive

- Relevance: LOW

- As Found: Unknown

- ID: M12406

- Name: Neuroma

- Relevance: LOW

- As Found: Unknown

- ID: M20461

- Name: Nerve Sheath Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12325

- Name: Neoplasms, Nerve Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11460

- Name: Mediastinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16655

- Name: Thoracic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: LOW

- As Found: Unknown

- ID: T2475

- Name: Germ Cells Tumors

- Relevance: HIGH

- As Found: Germ cell tumor

- ID: T5139

- Name: Schwannoma

- Relevance: HIGH

- As Found: Schwannoma

- ID: T5647

- Name: Thymic Epithelial Tumor

- Relevance: HIGH

- As Found: Thymic Epithelial Tumor

- ID: T4091

- Name: Neuroendocrine Tumor

- Relevance: LOW

- As Found: Unknown

- ID: T4092

- Name: Neuroepithelioma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

- ID: D000013724

- Term: Teratoma

- ID: D000009442

- Term: Neurilemmoma

- ID: D000008479

- Term: Mediastinal Neoplasms

- ID: D000008476

- Term: Mediastinal Cyst

### Misc Info Module

- Version Holder: 2024-05-31
