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Trial Title:
Predictive Value of Serum and Tissue Molecular Markers and Imaging Features in the Invasiveness and Prognosis of Pituitary Neuroendocrine Tumors
NCT ID:
NCT06015802
Condition:
Pituitary Adenoma
Neuroendocrine Tumors
Conditions: Official terms:
Adenoma
Neuroendocrine Tumors
Pituitary Neoplasms
Pituitary Diseases
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
diagnosed and treated reasonably according to the clinical guidelines and clinical pathways
Description:
The clinical data and biological specimens of the selected patients were collected, and
the patients were diagnosed and treated reasonably according to the clinical guidelines
and clinical pathways. The prognosis and outcome of the disease within 5 years after
discharge were observed.
Arm group label:
Pituitary neuroendocrine tumors
Summary:
As the clinical manifestations of pituitary neuroendocrine tumors vary greatly, 2.7-15%
of them are resistant to conventional treatments such as surgery, drug therapy and
radiotherapy, and often relapse or regrow in the early postoperative period, which is
invasive and has a poor prognosis. Therefore, it is important to find imaging,
histological or serum molecular markers for early prediction of the invasiveness and
clinical prognosis of pituitary neuroendocrine tumors. The aim of this study is to
observe the changes of biomarkers and imaging features in serum or tissues of pituitary
neuroendocrine tumors during the course of disease and treatment, and to explore the
biomarkers and imaging features that can predict the proliferation, progression and
recurrence risk of pituitary neuroendocrine tumors after medical or surgical treatment.
Criteria for eligibility:
Study pop:
Patients with pituitary neuroendocrine tumors: pituitary adenoma was diagnosed by
clinical imaging, with or without pituitary hormone secretion function was confirmed by
pituitary hormone detection.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
Patients with pituitary neuroendocrine tumors: pituitary adenoma was diagnosed by
clinical imaging, with or without pituitary hormone secretion function was confirmed by
pituitary hormone detection.
Exclusion Criteria:
1. Previous pathological specimen suggested pituitary carcinoma.
2. always have received radiation and chemotherapy or immune and targeted therapy of
the patients.
3. with known genetic syndrome can cause excessive secretion of hormones (such as
Carney syndrome, McCune - Albright syndrome, multiple endocrine neoplasia type 1,
acute interstitial pneumonia) patients.
4. there are ectopic neuroendocrine tumor patients.
5. within one month before the screening for major surgery, or within 3 months before
screening for patients with sphenoid pituitary surgery.
6. crisis of gland function (the pituitary gland, thyroid crisis, adrenal crisis).
7. peripheral glands or other solid tumors in patients with severe disease or blood
system.
8. serious organ damage such as heart, kidney, liver, etc.
9. with severe mental or nervous system disease.
10. serious high blood glucose or poorly controlled hypertension or emergency patients.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanbing Li, MD,PhD
Phone:
8602087334331
Email:
easd04lyb@126.com
Investigator:
Last name:
Yanbing Li, MD,PhD
Email:
Principal Investigator
Start date:
April 1, 2021
Completion date:
March 2029
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06015802