Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Pituitary Diseases
• Intervention / Treatment: Procedure: Surgical Removal; Procedure: Biopsy

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Yong Yao, MD; Phone Number: +8669152530; Email: yaoyong@pumch.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Yong Yao, MD; Phone Number: +8669152530; Email: yaoyong@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pituitary Complex and Rare Diseases; 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.

Procedure: Surgical Removal; Resection of pituitary pathologies.; Procedure: Biopsy; Taking a small tissue or liquid sample from the pituitary pathologies and the affected area for examination and diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission	Hormonal normalization and free of pathologies	Postoperative one week and extends to the latest follow-up, estimated at up to 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Yong Yao, MD, Department of Neurosurgery, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Disease Attributes; Hypothalamic Diseases; Pituitary Diseases; Rare Diseases
• Other Study ID Numbers: K5112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No