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

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.

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Key information

Conditions

Pituitary Adenoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Tumors Pituitary Diseases Pituitary Neoplasms Supratentorial Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

endocrinology department of the first affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Yanbing Li, MD,PhD

CONTACT

[email protected]

8602087334331

Yanbing Li, MD,PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Previous pathological specimen suggested pituitary carcinoma.
always have received radiation and chemotherapy or immune and targeted therapy of the patients.
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.
there are ectopic neuroendocrine tumor patients.
within one month before the screening for major surgery, or within 3 months before screening for patients with sphenoid pituitary surgery.
crisis of gland function (the pituitary gland, thyroid crisis, adrenal crisis).
peripheral glands or other solid tumors in patients with severe disease or blood system.
serious organ damage such as heart, kidney, liver, etc.
with severe mental or nervous system disease.
serious high blood glucose or poorly controlled hypertension or emergency patients.

Treatment and study plan

diagnosed and treated reasonably according to the clinical guidelines and clinical pathways

Other

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.

Primary outcomes

Disease progression or recurrence after surgery

Time frame: up to 5 years

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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2029
First posted: Aug 29, 2023
Registry last updated: Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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