ClinicalTrials.gg
RecruitingNCT06705036Updated Nov 26, 2024

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

An observational study in Pituitary Tumor, sponsored by Shanghai Zhongshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-26.

Sponsored by Shanghai Zhongshan Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 2 years later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
20
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 30 studies in Pituitary Neoplasms with a site in China — 8 open to participants now, 11 under way, none of them phase 3. Pituitary Neoplasms · China.

Planned enrollment
15th of 15
20 · median 200
Started
2024
with 2 others
Observational
15 of 30
3 open now
Primary completion
2025-11
later than 5 of 10 live
Registered
27th of 30
by date
Lead sponsor
1 of 30
Shanghai Zhongshan Hospital

Among the 30 studies in Pituitary Neoplasms with a site in China, this one is the 15th largest by planned enrollment of the 15 observational ones that give a count, is one of 3 that started in 2024, is one of 15 observational ones, reaches primary completion later than 5 of the 10 other live ones, and was the 27th registered.

Pituitary Neoplasms

200 studies on the registry are indexed under Pituitary Neoplasms; 51 are open to participants now.

Browse Pituitary Neoplasms studies →

Open to participants now

8 of the 30 studies in Pituitary Neoplasms with a site in China are open now. Recruiting first, the newest first:

2 more — sign in →

All 8 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 36 Pituitary Neoplasms studies recruiting now, 14 (39%) set no upper age limit and 10 (28%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed description

This study focuses on investigating the molecular and biological differences between the intrasellar and cavernous sinus regions in invasive pituitary tumors to uncover mechanisms driving their aggressiveness and to identify potential therapeutic targets.

The research begins with sample collection, selecting 20 patients with invasive pituitary tumors based on inclusion and exclusion criteria. Paired tumor tissue samples are collected from the intrasellar and cavernous sinus regions of each patient, ensuring accuracy and completeness. These samples are then preserved at -80°C to maintain quality for subsequent multi-omics analyses.

Next, multi-omics analysis is conducted to examine molecular differences. Proteomics, using technologies like mass spectrometry or protein arrays, identifies differentially expressed proteins between the two regions and assesses their biological functions. Transcriptomics, through RNA sequencing, explores significant differences in gene expression and associated pathways. These approaches aim to uncover molecular mechanisms driving the tumor's invasive behavior.

Imaging analysis complements the molecular studies by utilizing preoperative imaging data, such as MRI or CT, to evaluate tumor morphology, invasion depth, and the impact on surrounding tissues. This provides a structural and functional context for the molecular findings.

Biological experiments follow to validate key discoveries. In vitro studies using cell lines or organoid models test the role of specific genes or pathways identified in the omics analyses, such as through gene knockout or overexpression. Mechanistic studies focus on understanding how molecular differences between the intrasellar and cavernous sinus regions influence tumor behaviors like invasion, proliferation, and migration. Validation experiments, including Western blotting or immunofluorescence, confirm the expression patterns and regional specificity of significant molecules.

Finally, data integration and analysis combine findings from proteomics, transcriptomics, and metabolomics with imaging features. Bioinformatics tools integrate these datasets to identify biomarkers and pathways associated with the tumor's invasiveness and regional specificity. Imaging-omics integration links molecular profiles with imaging characteristics, while rigorous statistical analysis ensures the robustness and significance of the results, accounting for potential confounding factors.

This comprehensive approach aims to provide new insights into the biological mechanisms of invasive pituitary tumors and identify effective targets for innovative therapeutic strategies.

03

Conditions studied

  • Pituitary Tumor

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Keywords

  • cavernous sinus
  • intrasellar
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Invasive pituitary tumors involving the cavernous sinus
  2. Retrospective inclusion of patients who have signed forms for the donation of biological samples and health-related information
  3. Age range: 18-80 years
  4. Subjects are willing to participate in this study

Exclusion criteria

Exclusion Criteria:

  1. Non-invasive pituitary tumors
  2. Pregnant or breastfeeding
  3. Other conditions deemed unsuitable for participation in this clinical trial as assessed by the physician
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Othersurgery

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

06

What researchers measure

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

    Time frame: 2025/12/01-2026/12/01

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2024 (actual). Primary completion is estimated for Nov 2025, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2024
First posted
Nov 26, 2024
StartActual
Nov 1, 2024
Primary completionEst.
Nov 1, 2025
CompletionEst.
Dec 31, 2026
Last update
Nov 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06705036
Responsible party
Sponsor
First posted
Nov 26, 2024
Start date
Nov 1, 2024
Primary completion
Nov 1, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 26, 2024

Study contacts

Tao Xie
Contact
xie.tao@zs-hospital.sh.cn
+8613524281211
Tao Xie
study director · Fudan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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