Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases

Recruiting

• Conditions: Pituitary Diseases
• Interventions: Procedure: Surgical Removal; Procedure: Biopsy

• Registration Number: NCT06435195
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pituitary Complex and Rare Diseases	Surgical Removal	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.
Pituitary Complex and Rare Diseases	Biopsy	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.

Primary Outcome Measures

Name	Time	Method
Remission	Postoperative one week and extends to the latest follow-up, estimated at up to 3 years	Hormonal normalization and free of pathologies

Secondary Outcome Measures

Name	Time	Method
Disease Comorbidities	From patient admission to an evaluation period extending up to the latest follow-up, estimately up to 3 years	Systemic changes accompanied with Pituitary Complex and Rare Diseases
Postoperative complications	Postoperative one week and extends to the latest follow-up, estimated at up to 3 years	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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China