Clinical trial NCT06015802: Predictive Value of Serum and Tissue Molecular Markers and Imaging Features in the Invasiveness and Prognosis of Pituitary Neuroendocrine Tumors
Official title: Predictive Value of Serum and Tissue Molecular Markers and Imaging Features in the Invasiveness and Prognosis of Pituitary Neuroendocrine Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pituitary Adenoma
Neuroendocrine Tumors
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Disease progression or recurrence after surgery
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: endocrinology department of the first affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: