Pituitary Adenoma 1, Acth-SecretingNCT04021212
Pituitary Adenoma and Serum Lipid
An observational study of Pituitary Adenoma 1, Acth-Secreting, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
Pituitary adenomas are usually benign monoclonal neoplasms caused by a mixture of pituicyte alterations together with a changed endocrine and paracrine regulatory milieu. Thus, it can cause serious health problems such as abnormal target organ function, pain, disability and even death. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pituitary Adenoma 1, Acth-Secreting
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 diagnosed with pituitary adenomas and underwent an endoscopic transsphenoidal approach at the Shandong Provincial Hospital affiliated with Shandong University. All adenomas were resected by transsphenoidal surgery and identified by histological diagnoses.
Who may be able to join
- Patients diagnosed with pituitary adenomas
- All adenomas were resected by transsphenoidal surgery and identified by histological diagnoses.
Who cannot join
- Missing vital data, such as age, gender, serum lipid profile, pathology reports;
- Complications or conditions that affect pituitary status and lipid metabolism, such as pregnancy, malignant adenomas or severe hepatic or renal dysfunction and
- Use of any medication that affects the pituitary or lipid metabolism, including statins, fibrates, thyroid hormones, anti-thyroid drugs, iodine, amiodarone, alemtuzumab, lithium, tyrosine kinase inhibitors, interferon, estrogens, androgens,glucocorticoids, nonsteroidal anti-inflammatory drugs, antiepileptic drugs, rifampicin, furosemide, heparin or β-adrenoceptor blockers in the past 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
Shanshan Shao, 86-531-68776094, shaoshanshan11@126.com
About this study
Official title: Effects of Pituitary Adenoma Resection on Serum Lipid Level
Pituitary adenomas are usually benign monoclonal neoplasms caused by a mixture of pituicyte alterations together with a changed endocrine and paracrine regulatory milieu. Thus, it can cause serious health problems such as abnormal target organ function, pain, disability and even death. In clinical practice, we found many patients with pituitary adenomas are usually accompanied by hyperlipidemia, which is the main cause of cardiovascular diseases. However, it has been unclear if there is an association between pituitary adenomas and serum lipid profile. In the present study, we aim to focus on the patients with pituitary adenomas and their lipid profile before and after operation including first occurrence and recurrence.
- Conditions
- Pituitary Adenoma 1, Acth-Secreting
- Keywords
- Pituitary, Pituitary Adenoma, Serum Lipid Levels, Resection, Recurrence
- Medical subject headings
- Pituitary Diseases, Pituitary Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pituitary adenomas resection | Patients suffers from pituitary adenomas and undergo transsphenoidal surgery for at least once |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum lipid levels
Measured: Measured at pre-operative and 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Sep 2020
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary Adenoma 1, Acth-SecretingStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jia-jun Zhao, Shandong Provincial Hospital
- Investigators
- Jiajun Zhao, Study chair, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021212
- Sponsor's protocol ID
- 20190712
- Status last verified
- May 2022
- First submitted
- 15 Jul 2019
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pituitary Adenoma Resection on Serum Lipid Level
- ClinicalTrials.gov ID
- NCT04021212
- Acronym / sponsor ID
- 20190712
- Conditions
- Pituitary Adenoma 1, Acth-Secreting
- Keywords
- Pituitary, Pituitary Adenoma, Serum Lipid Levels, Resection, Recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 16 Jul 2019 (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.
Pituitary adenomas are usually benign monoclonal neoplasms caused by a mixture of pituicyte alterations together with a changed endocrine and paracrine regulatory milieu. Thus, it can cause serious health problems such as abnormal target organ function, pain, disability and even death. In clinical practice, we found many patients with pituitary adenomas are usually accompanied by hyperlipidemia, which is the main cause of cardiovascular diseases. However, it has been unclear if there is an association between pituitary adenomas and serum lipid profile. In the present study, we aim to focus on the patients with pituitary adenomas and their lipid profile before and after operation including first occurrence and recurrence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pituitary adenomas resection | – | –Patients suffers from pituitary adenomas and undergo transsphenoidal surgery for at least once |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with pituitary adenomas and underwent an endoscopic transsphenoidal approach at the Shandong Provincial Hospital affiliated with Shandong University. All adenomas were resected by transsphenoidal surgery and identified by histological diagnoses.
Key inclusion criteria (2 listed)
- Patients diagnosed with pituitary adenomas
- All adenomas were resected by transsphenoidal surgery and identified by histological diagnoses.
Key exclusion criteria (3 listed)
- Missing vital data, such as age, gender, serum lipid profile, pathology reports;
- Complications or conditions that affect pituitary status and lipid metabolism, such as pregnancy, malignant adenomas or severe hepatic or renal dysfunction and
- Use of any medication that affects the pituitary or lipid metabolism, including statins, fibrates, thyroid hormones, anti-thyroid drugs, iodine, amiodarone, alemtuzumab, lithium, tyrosine kinase inhibitors, interferon, estrogens, androgens,glucocorticoids, nonsteroidal anti-inflammatory drugs, antiepileptic drugs, rifampicin, furosemide, heparin or β-adrenoceptor blockers in the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in serum lipid levels
Time frame: Measured at pre-operative and 6 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
Jiajun Zhao study chair
Shandong Provincial 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 Adenoma 1, Acth-Secreting, run by Shandong Provincial 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: status not confirmed, as of the sponsor's last update on 11 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ling Gao (+86 53168776910, linggao@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum lipid levels (time frame: Measured at pre-operative and 6 months after operation). 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 11 May 2022.