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

NCT ID: NCT06015802

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2029-03-31

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.

Conditions

Pituitary Adenoma; Neuroendocrine Tumors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanbing Li

director of endocrinology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yanbing Li, MD,PhD

Role: primary

easd04lyb@126.com

8602087334331

Other Identifiers

2021450

Identifier Type: -

Identifier Source: org_study_id