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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06015802
Collaborator
(none)
300
1
95
3.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: diagnosed and treated reasonably according to the clinical guidelines and clinical pathways

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predictive Value of Serum and Tissue Molecular Markers and Imaging Features in the Invasiveness and Prognosis of Pituitary Neuroendocrine Tumors
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2029

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Disease progression or recurrence after surgery [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 endocrinology department of the first affiliated hospital of Sun Yat-sen University Guangzhou Guangdong China 510080

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yanbing Li, director of endocrinology department, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT06015802
Other Study ID Numbers:
  • 2021450
First Posted:
Aug 29, 2023
Last Update Posted:
Aug 29, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 29, 2023