## Protocol Section
### Identification Module
**NCT ID:** NCT06435195

**Brief Title:** Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases

**Official Title:** Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases

#### Organization Study ID Info
**ID:** K5112
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
### Status Module
#### Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking Union Medical College Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The goal of this observational study is to systematically describe the clinical characteristics and outcomes of patients with pituitary complex and rare diseases at Peking Union Medical College Hospital. The main questions it aims to answer are:

* What are the influencing factors and rates of remission?
* What are the comorbidities associated with these diseases?
* What are the perioperative events, radiological findings, and pathological features?

Researchers will compare different patient groups to see if there are significant differences in these outcomes.

Participants will:

* Undergo detailed clinical evaluations.
* Provide medical history and data for analysis.
* Participate in follow-up assessments to monitor disease progression and treatment outcomes.

**Detailed Description:** The study aims to provide a comprehensive analysis of pituitary complex and rare diseases at Peking Union Medical College Hospital. By leveraging a large cohort, the research will explore various clinical characteristics and outcomes. Specifically, the study will examine influencing factors and rates of remission, the presence of comorbidities, and perioperative events. Additionally, it will evaluate radiological findings and pathological features to better understand these conditions. Through this detailed investigation, the study seeks to enhance knowledge and inform clinical practice regarding the management and prognosis of pituitary complex and rare diseases.

### Conditions Module

**Conditions:**

- Pituitary Diseases

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 3000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The Pituitary Complex and Rare Diseases cohort consists of patients diagnosed with various pituitary disorders, including but not limited to pituitary adenomas, craniopharyngiomas, Rathke's cleft cysts, sellar region germ cell tumors, cavernous sinus syndrome, and other diseases. Patients requiring surgical resection or biopsy of pituitary pathologies will undergo transsphenoidal surgery or craniotomy.

**Intervention Names:**

- Procedure: Surgical Removal

- Procedure: Biopsy

**Label:** Pituitary Complex and Rare Diseases

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pituitary Complex and Rare Diseases

**Description:** Resection of pituitary pathologies.

**Name:** Surgical Removal

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Pituitary Complex and Rare Diseases

**Description:** Taking a small tissue or liquid sample from the pituitary pathologies and the affected area for examination and diagnosis

**Name:** Biopsy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Hormonal normalization and free of pathologies

**Measure:** Remission

**Time Frame:** Postoperative one week and extends to the latest follow-up, estimated at up to 3 years

#### Secondary Outcomes

**Description:** Systemic changes accompanied with Pituitary Complex and Rare Diseases

**Measure:** Disease Comorbidities

**Time Frame:** From patient admission to an evaluation period extending up to the latest follow-up, estimately up to 3 years

**Description:** adverse events or medical issues that arise after a surgical procedure on the pituitary diseases.These complications can include various problems such as bleeding, infection, hormonal imbalances, cerebrospinal fluid leaks, vision changes, or neurological deficits

**Measure:** Postoperative complications

**Time Frame:** Postoperative one week and extends to the latest follow-up, estimated at up to 3 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosed with rare sellar diseases including but not limited to pituitary adenomas (such as Thyrotropin-secreting pituitary adenomas, GH-secreting adenomas), craniopharyngiomas, Rathke's cleft cysts, sellar region germ cell tumors, cavernous sinus syndrome, and other diseases
* Detailed medical history, including clinical symptoms, treatment plans and follow-up outcomes

Exclusion Criteria:

* Incomplete medical records, especially missing key imaging diagnostic results
* Patients with coexisting primary central nervous system diseases unrelated to sellar region diseases (such as severe traumatic brain injury)
* Patients whose sellar region pathological diagnosis was changed or overturned during the follow-up period

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Patients who are diagnosed with Pituitary Complex and Rare Diseases at Peking Union Medical College Hospital

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yaoyong@pumch.cn

**Name:** Yong Yao, MD

**Phone:** +8669152530

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

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

- **Name:** Yong Yao, MD

- **Phone:** +8669152530

- **Role:** CONTACT

**Country:** China

**Facility:** Peking Union Medical College Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100730

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Neurosurgery, Peking Union Medical College Hospital

**Name:** Yong Yao, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007027

- Term: Hypothalamic Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M13791

- Name: Pituitary Diseases

- Relevance: HIGH

- As Found: Pituitary

- ID: M24518

- Name: Rare Diseases

- Relevance: HIGH

- As Found: Rare disease

- ID: M10077

- Name: Hypothalamic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010900

- Term: Pituitary Diseases

- ID: D000035583

- Term: Rare Diseases

### Misc Info Module

- Version Holder: 2024-05-31
