Predictive Value of Serum and Tissue Molecular Markers and Imaging Features in the Invasiveness and Prognosis of Pituitary Neuroendocrine Tumors

Neuroendocrine Tumors Clinical Trial

Official title:

Predictive Value of Serum and Tissue Molecular Markers and Imaging Features in the Invasiveness and Prognosis of Pituitary Neuroendocrine Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015802
• Other study ID #: 2021450
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Adenoma
• Neuroendocrine Tumors
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

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