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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06015802
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sun Yat-sen University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pituitary Adenoma, Neuroendocrine Tumors

Arms & Interventions

Arms

: Pituitary neuroendocrine tumors

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.

Interventions

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.

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