NCT04953468

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

June 28, 2021

Last Update Submit

July 7, 2021

Conditions

Keywords

gliomaANXA2 Expressionperiatumoral edema zone

Outcome Measures

Primary Outcomes (1)

  • 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

    From the date of surgery to the date of death from any cause, assessed up to 18 weeks.

Study Arms (4)

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

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

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

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

Interventions

The expression level of ANXA2 protein in glioma and PTBE was detected by immunohistochemistry

ANXA2 high expression in PTBEANXA2 high expression in gliomaANXA2 low expression in PTBEANXA2 low expression in glioma

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Immunohistochemistry of glioma tissue

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Yang Jun

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Xin

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 8, 2021

Study Start

February 19, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2023

Last Updated

July 8, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations