GliomaNCT04953468
Expression of ANXA2 in the Extracellular Space in the Microenvironment of Periumoral Edema Promotes Glioma Invasion
An observational study of Glioma, run by Peking University Third Hospital at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioma
- What is being tested?
- expression level of ANXA2 protein
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2021to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- All glioma patients who did not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Chen Xin contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yang Jun, 13901291211, 13901291211@163.com
About this study
Official title: 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
Read the 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
- Conditions
- Glioma
- Being tested
- expression level of ANXA2 protein
- Keywords
- glioma, ANXA2 Expression, periatumoral edema zone
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expression level of ANXA2 proteinDiagnostic test
The expression level of ANXA2 protein in glioma and PTBE was detected by immunohistochemistry
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: expression level of ANXA2 protein | |
| 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 Receives: Diagnostic Test: expression level of ANXA2 protein | |
| 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 Receives: Diagnostic Test: expression level of ANXA2 protein | |
| 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 Receives: Diagnostic Test: expression level of ANXA2 protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
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
Measured: From the date of surgery to the date of death from any cause, assessed up to 18 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start19 Feb 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Jun, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953468
- Sponsor's protocol ID
- M2021020
- Status last verified
- Jul 2021
- First submitted
- 28 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Mechanism of the Expression of ANXA2 in the Extracellular Space in the Microenvironment of Periumoral Edema to Promote Glioma Invasion
- ClinicalTrials.gov ID
- NCT04953468
- Acronym / sponsor ID
- M2021020
- Conditions
- Glioma
- Keywords
- glioma, ANXA2 Expression, periatumoral edema zone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ANXA2 high expression in glioma | – | Diagnostic Test: expression level of ANXA2 proteinWe 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 |
| ANXA2 low expression in glioma | – | Diagnostic Test: expression level of ANXA2 proteinWe 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 |
| ANXA2 high expression in PTBE | – | Diagnostic Test: expression level of ANXA2 proteinWe 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 |
| ANXA2 low expression in PTBE | – | Diagnostic Test: expression level of ANXA2 proteinWe 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- All glioma patients who did not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| expression level of ANXA2 proteinThe expression level of ANXA2 protein in glioma and PTBE was detected by immunohistochemistry | Diagnostic test | ANXA2 high expression in PTBE, ANXA2 high expression in glioma, ANXA2 low expression in PTBE, ANXA2 low expression in glioma |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Xin contact
Yang Jun principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Jun (13901291211, 13901291211@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From the date of surgery to the date of death from any cause, assessed up to 18 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.