Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases

NCT06435195 | Recruiting DMC

• 1 other identifier: K5112
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Diseases

Outcome Measures

Primary Outcomes (1)

• Remission

  Hormonal normalization and free of pathologies

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

Secondary Outcomes (2)

• Disease Comorbidities

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

• Postoperative complications

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

Study Arms (1)

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; Procedure: Biopsy

Interventions

Surgical Removal PROCEDURE

Resection of pituitary pathologies.

Pituitary Complex and Rare Diseases

Biopsy PROCEDURE

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

Pituitary Complex and Rare Diseases

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Pituitary Diseases

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yong Yao, MD

  Department of Neurosurgery, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Yao, MD

CONTACT

+8669152530; yaoyong@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 30, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

CN (1)