Differential Study of Invasive Pituitary Adenomas in the Sellar and Cavernous Sinus Regions

NCT06705036 | Recruiting

• 1 other identifier: KY2024683
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves collecting paired tumor samples from intrasellar and cavernous sinus regions of 20 invasive pituitary tumor patients, preserving them at -80°C for quality multi-omics analysis. Proteomics and transcriptomics are employed to identify molecular differences, while imaging data (MRI/CT) assesses tumor morphology and invasion. In vitro experiments and mechanistic studies validate key findings, exploring how regional molecular differences affect tumor behavior. Data integration combines multi-omics and imaging features to uncover biomarkers and pathways associated with invasiveness and regional specificity, with statistical analysis ensuring significance and reliability.

Conditions

Pituitary Tumor

Keywords

cavernous sinus; intrasellar

Outcome Measures

Primary Outcomes (1)

• Differences in pathological features of tumors

  Cell morphology, proliferation index (e.g. Ki-67), angiogenesis, and other pathological features of tumor tissue in different regions were analyzed to explore region-specific invasive manifestations

  2025/12/01-2026/12/01

Study Arms (2)

pituitary tumors in cavernous sinus group

The 20 pituitary tumor samples in this group were obtained from the cavernous sinus region removed during surgery and were paired with pituitary tumors in the intralellar region

Other: surgery

pituitary tumors in sellar group

The 20 pituitary tumors in this group were obtained from intrasellar samples removed during surgery and were paired with pituitary tumors in the cavernous sinus region

Other: surgery

Interventions

surgery OTHER

Samples were obtained from patients by surgical excision and matched into groups

pituitary tumors in cavernous sinus group; pituitary tumors in sellar group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-80 years who are clinically diagnosed with invasive pituitary tumors involving the cavernous sinus, have signed the informed consent form, and are willing to participate in this study.

You may qualify if:

• Invasive pituitary tumors involving the cavernous sinus
• Age range: 18-80 years
• Subjects are willing to participate in this study

You may not qualify if:

• Non-invasive pituitary tumors
• Pregnant or breastfeeding
• Other conditions deemed unsuitable for participation in this clinical trial as assessed by the physician

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Paired pituitary tumors from the sella and cavernous sinus of the same patient

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Tao Xie

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Tao Xie

CONTACT

+8613524281211; xie.tao@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: November 26, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)