- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04953468
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
Recruiting
Conditions
Intervention / Treatment
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
Observational
Enrollment (Anticipated)
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
- Name: Yang Jun
- Phone Number: 13901291211
- Email: 13901291211@163.com
Study Contact Backup
- Name: Chen Xin
- Phone Number: 13611061786
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100191
- Recruiting
- Peking University Third Hospital
-
Contact:
- Yang Jun
- Phone Number: 13901291211
- Email: 13901291211@163.com
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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
|
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
|
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
|
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
|
The expression level of ANXA2 protein in glioma and PTBE was detected by immunohistochemistry
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- 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)
February 19, 2021
Primary Completion (Anticipated)
August 1, 2022
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
June 28, 2021
First Submitted That Met QC Criteria
July 7, 2021
First Posted (Actual)
July 8, 2021
Study Record Updates
Last Update Posted (Actual)
July 8, 2021
Last Update Submitted That Met QC Criteria
July 7, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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