Expression of ANXA2 in the Extracellular Space in the Microenvironment of Periumoral Edema Promotes Glioma Invasion

July 7, 2021 updated by: Peking University Third Hospital

Study on the Mechanism of the Expression of ANXA2 in the Extracellular Space in the Microenvironment of Periumoral Edema to Promote Glioma Invasion

The prognostic value of ANXA2 expression in tumor tissue and PTBE was analyzed, so as to seek new therapies to inhibit glioma invasion and improve the prognosis of glioma patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The main reason for the poor prognosis of glioma is the invasion of tumor cells along the extracellular space (ECS) in the periatumoral edema zone (PTBE).Previous studies have shown that ANXA2 is highly expressed in glioma and promotes tumor growth and invasion, while its expression in the PTBE microenvironment of glioma and its mechanism of action on tumor invasion have not been reported.Previous study found that ANXA2 was overexpressed in gliomas and was associated with poor prognosis, and the low expression of ANXA2 significantly inhibited tumor invasion in vitro.Relevant studies have also confirmed that as an exocrine protein, it mainly plays a role in ECS, and it has previously been carried out on the tissue structure of ECS in tumor microenvironment.Therefore, investigators planned to study the mechanism of ANXA2 expression in PTBE microenvironment ECS on tumor invasion.This project aims to take glioma related issues as the research object and analyze tumor tissue and tumor tissue

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Chen Xin
  • Phone Number: 13611061786

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (aged 18-75 years) who underwent microsurgical resection of glioma in the Neurosurgery Department of Peking University Third Hospital between 2018 and 2020

Description

Inclusion Criteria:

  • Patients who have undergone microneurosurgical resection of the tumor in our hospital and are pathologically confirmed to be supratentorial glioma;
  • Preserving the remaining tissue samples of paired gliomas and PTBE for pathological examination;
  • The patients agreed to be enrolled and signed the informed consent;
  • The clinical data of the patients are complete and not lost;
  • No serious complications occurred after surgery.

Exclusion Criteria:

  • All glioma patients who did not meet the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ANXA2 high expression in glioma
We plan to grade the dyeing intensity of ANXA2 as follows: level 0 for non-stained, level 1 for lighter colored, level 3 for dark brown, and level 2 for those between the latter two.We planned to divide the staining proportion into 5 grades: grade 0 for those without staining, grade 1 for those with staining proportion < 10%, grade 2 for those with staining proportion ≥10% and < 50%, grade 3 for those with staining proportion ≥50% and < 80%, and grade 4 for those with staining proportion ≥ 80%.Finally, staining intensity grading × staining proportion grading = expression level was calculated In glioma tissues, samples with expression level ≥6 points were identified as the ANXA2 high expression group
Diagnostic test: expression level of ANXA2 protein
The expression level of ANXA2 protein in glioma and PTBE was detected by immunohistochemistry
ANXA2 low expression in glioma
We plan to grade the dyeing intensity of ANXA2 as follows: level 0 for non-stained, level 1 for lighter colored, level 3 for dark brown, and level 2 for those between the latter two.We planned to divide the staining proportion into 5 grades: grade 0 for those without staining, grade 1 for those with staining proportion < 10%, grade 2 for those with staining proportion ≥10% and < 50%, grade 3 for those with staining proportion ≥50% and < 80%, and grade 4 for those with staining proportion ≥ 80%.Finally, staining intensity grading × staining proportion grading = expression level was calculated In glioma tissues, samples with expression level <6 points were identified as the ANXA2 low expression group
Diagnostic test: expression level of ANXA2 protein
The expression level of ANXA2 protein in glioma and PTBE was detected by immunohistochemistry
ANXA2 high expression in PTBE
We plan to grade the dyeing intensity of ANXA2 as follows: level 0 for non-stained, level 1 for lighter colored, level 3 for dark brown, and level 2 for those between the latter two.We planned to divide the staining proportion into 5 grades: grade 0 for those without staining, grade 1 for those with staining proportion < 10%, grade 2 for those with staining proportion ≥10% and < 50%, grade 3 for those with staining proportion ≥50% and < 80%, and grade 4 for those with staining proportion ≥ 80%.Finally, staining intensity grading × staining proportion grading = expression level was calculated In PTBE, samples with expression level ≥2 were regarded as the ANXA2 high expression group
Diagnostic test: expression level of ANXA2 protein
The expression level of ANXA2 protein in glioma and PTBE was detected by immunohistochemistry
ANXA2 low expression in PTBE
We plan to grade the dyeing intensity of ANXA2 as follows: level 0 for non-stained, level 1 for lighter colored, level 3 for dark brown, and level 2 for those between the latter two.We planned to divide the staining proportion into 5 grades: grade 0 for those without staining, grade 1 for those with staining proportion < 10%, grade 2 for those with staining proportion ≥10% and < 50%, grade 3 for those with staining proportion ≥50% and < 80%, and grade 4 for those with staining proportion ≥ 80%.Finally, staining intensity grading × staining proportion grading = expression level was calculated In PTBE, samples with expression level <2 were regarded as the ANXA2 low expression group
Diagnostic test: expression level of ANXA2 protein
The expression level of ANXA2 protein in glioma and PTBE was detected by immunohistochemistry

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From the date of surgery to the date of death from any cause, assessed up to 18 weeks.
Follow-up information was collected by telephone follow-up and regular review when patients returned to the hospital. Telephone follow-up was conducted every 3 months, and the main follow-up content was survival time, and the end point of follow-up was to the patient's death
From the date of surgery to the date of death from any cause, assessed up to 18 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yang Jun, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2021020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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