Pituitary DiseasesNCT06435195
Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases
An observational study of Pituitary Diseases, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pituitary Diseases
- What is being tested?
- Surgical Removal and Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are diagnosed with Pituitary Complex and Rare Diseases at Peking Union Medical College Hospital
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yong Yao, MD, +8669152530, yaoyong@pumch.cn
About this study
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?
Read more
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.
Read the 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
- Pituitary Diseases
- Being tested
- Surgical Removal, Biopsy
- Medical subject headings
- Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical RemovalProcedure or surgery
Resection of pituitary pathologies.
BiopsyProcedure or surgery
Taking a small tissue or liquid sample from the pituitary pathologies and the affected area for examination and diagnosis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Surgical Removal; Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission
Hormonal normalization and free of pathologies
Measured: Postoperative one week and extends to the latest follow-up, estimated at up to 3 years
Secondary outcomes (2)
Disease Comorbidities
Systemic changes accompanied with Pituitary Complex and Rare Diseases
Measured: 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
Measured: Postoperative one week and extends to the latest follow-up, estimated at up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jan 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary DiseasesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Yao, MD, Principal investigator, Department of Neurosurgery, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435195
- Sponsor's protocol ID
- K5112
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases
- ClinicalTrials.gov ID
- NCT06435195
- Acronym / sponsor ID
- K5112
- Conditions
- Pituitary Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pituitary Complex and Rare Diseases | – | Procedure: Surgical Removal, Procedure: BiopsyThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are diagnosed with Pituitary Complex and Rare Diseases at Peking Union Medical College Hospital
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical RemovalResection of pituitary pathologies. | Procedure or surgery | Pituitary Complex and Rare Diseases |
| BiopsyTaking a small tissue or liquid sample from the pituitary pathologies and the affected area for examination and diagnosis | Procedure or surgery | Pituitary Complex and Rare Diseases |
Primary outcome
Remission
Time frame: Postoperative one week and extends to the latest follow-up, estimated at up to 3 years
Hormonal normalization and free of pathologies
2 secondary outcomes
Disease Comorbidities
Time frame: From patient admission to an evaluation period extending up to the latest follow-up, estimately up to 3 years
Postoperative complications
Time frame: Postoperative one week and extends to the latest follow-up, estimated at up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong Yao, MD principal investigator
Department of Neurosurgery, Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Diseases, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Yao, MD (+8669152530, yaoyong@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission (time frame: Postoperative one week and extends to the latest follow-up, estimated at up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.