Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases

Pituitary Diseases Clinical Trial

Official title:

Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06435195
• Other study ID #: K5112
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Peking Union Medical College Hospital
• Contact: Yong Yao, MD
• Phone: +8669152530
• Email: yaoyong[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pituitary Diseases
• Rare Diseases

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission	Hormonal normalization and free of pathologies	Postoperative one week and extends to the latest follow-up, estimated at up to 3 years
Secondary	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
Secondary	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