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出境医 / 临床实验 / Pituitary Adenoma and Serum Lipid

Pituitary Adenoma and Serum Lipid

Study Description
Brief 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. 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.

Condition or disease
Pituitary Adenoma 1, Acth-Secreting

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of Pituitary Adenoma Resection on Serum Lipid Level
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024
Arms and Interventions
Group/Cohort
Patients with pituitary adenomas resection
Patients suffers from pituitary adenomas and undergo transsphenoidal surgery for at least once
Outcome Measures
Primary Outcome Measures :
  1. Change in serum lipid levels [ Time Frame: Measured at pre-operative and 6 months after operation ]

Biospecimen Retention:   Samples With DNA
serum，plasma, whole blood

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Patients diagnosed with pituitary adenomas
  2. All adenomas were resected by transsphenoidal surgery and identified by histological diagnoses.

Exclusion Criteria:

  1. Missing vital data, such as age, gender, serum lipid profile, pathology reports;
  2. Complications or conditions that affect pituitary status and lipid metabolism, such as pregnancy, malignant adenomas or severe hepatic or renal dysfunction and
  3. 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.
Contacts and Locations

Contacts
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Contact: Ling Gao +86 53168776910 linggao@sdu.edu.cn

Locations
Layout table for location information
China, Shandong
Shandong Provincial Hospital Recruiting
Jinan, Shandong, China, 250021
Contact: Shanshan Shao    86-531-68776094    shaoshanshan11@126.com   
Sponsors and Collaborators
Shandong Provincial Hospital
Investigators
Layout table for investigator information
Study Chair: Jiajun Zhao Shandong Provincial Hospital
Tracking Information
First Submitted Date July 15, 2019
First Posted Date July 16, 2019
Last Update Posted Date November 6, 2020
Actual Study Start Date September 1, 2020
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2019) 		Change in serum lipid levels [ Time Frame: Measured at pre-operative and 6 months after operation ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pituitary Adenoma and Serum Lipid
Official Title Effects of Pituitary Adenoma Resection on Serum Lipid Level
Brief 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. 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
serum，plasma, whole blood
Sampling Method Probability Sample
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.
Condition Pituitary Adenoma 1, Acth-Secreting
Intervention Not Provided
Study Groups/Cohorts Patients with pituitary adenomas resection
Patients suffers from pituitary adenomas and undergo transsphenoidal surgery for at least once
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 15, 2019) 		1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients diagnosed with pituitary adenomas
  2. All adenomas were resected by transsphenoidal surgery and identified by histological diagnoses.

Exclusion Criteria:

  1. Missing vital data, such as age, gender, serum lipid profile, pathology reports;
  2. Complications or conditions that affect pituitary status and lipid metabolism, such as pregnancy, malignant adenomas or severe hepatic or renal dysfunction and
  3. 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Ling Gao +86 53168776910 linggao@sdu.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04021212
Other Study ID Numbers 20190712
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Jia-jun Zhao, Shandong Provincial Hospital
Study Sponsor Shandong Provincial Hospital
Collaborators Not Provided
Investigators
Study Chair: Jiajun Zhao Shandong Provincial Hospital
PRS Account Shandong Provincial Hospital
Verification Date November 2020

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