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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06015802
Other study ID # 2021450
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date March 2029

Study information

Verified date August 2023
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date March 2029
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Intervention

Other:
diagnosed and treated reasonably according to the clinical guidelines and clinical pathways
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.

Locations

Country Name City State
China endocrinology department of the first affiliated hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease progression or recurrence after surgery Disease'recurrence'corresponded to tumour detection at MRI and/or hormone hypersecretion in previously cured patients, while disease'progression'indicated the increase in size of post-operative tumour remnant in nonfunctioning tumours and/or relapse of hormone hypersecretion in functioning ones up to 5 years
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