Role and Value of Inflammatory Markers in Brain Tumors : A Case Controlled Study

Completed

• Conditions: Brain Tumor
• Interventions: Diagnostic Test: Procalcitonin

• Registration Number: NCT04634188
• Lead Sponsor: Universitas Sumatera Utara

Brief Summary

This study is a case controlled analytical study that analyzes the relationship between levels of inflammatory markers with the type of brain tumor. Samples of 35 people were then categorized according to the variables above and analyzing to measure its significance

Detailed Description

This study is a case controlled analytical study to find the relationship between levels of inflammatory markers in patients with brain tumors. Samples were collected from patients at Haji Adam Malik Hospital in Medan, then the patient's blood serum was taken to be checked for these variables. Sample collection began in March - September 2020. The sample obtained was 35 people who met the inclusion and exclusion criteria.

Inclusion criteria:

1. Willing to be a sample

2. Complete medical records

3. Head scan and head contrast MRI have been performed to confirm the patient's diagnosis with a brain tumor

Exclusion criteria:

1. The patient's age is over 70 years

2. Patients with high comorbidities such as kidney failure, heart disease, diabetes, and others

3. Patients with a history of brain tumor surgery or previous brain tumor treatment

Samples were categorized based on demographic data (age and gender), then the samples were categorized based on the type of brain tumor suffered. Once categorized, the levels of inflammatory markers was examined. Specimens were taken from the patient's peripheral blood examination and analyzed in laboratorium. The results of these examinations are grouped on a nominal scale, and analyzed statistically.

Based on this analysis, it will be determined whether there is a significant relationship between levels of inflammatory markers in the incidence of brain tumors.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-09-01
• Study Completion: 2020-10-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-11
• Last Update Submitted: 2020-11-11
• Study First Posted: 2020-11-18
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Willing to be a sample
2. Complete medical records
3. Head scan and head contrast MRI have been performed to confirm the patient's diagnosis with a brain tumor

Exclusion Criteria

1. The patient's age is over 70 years
2. Patients with high comorbidities such as kidney failure, heart disease, diabetes, and others
3. Patients with a history of brain tumor surgery or previous brain tumor treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Meningioma Group	Procalcitonin	This group is based on the type of histopathology and MRI images that lead to a meningioma type brain tumor. After grouping, blood serum samples was collected to check the value of CRP, procalcitonin and NLR. The data were entered in a table and then compared with values from other types of brain tumors.
Glioma Group	Procalcitonin	This group is based on the type of histopathology and MRI images that lead to a glioma type brain tumor. After grouping, blood serum samples was collected to check the value of CRP, procalcitonin and NLR. The data were entered in a table and then compared with values from other types of brain tumors.
Brain Metastasis Group	Procalcitonin	This group is based on the type of histopathology and MRI images that lead to a metastasis brain tumor type After grouping, blood serum samples was collected to check the value of CRP, procalcitonin and NLR. The data were entered in a table and then compared with values from other types of brain tumors.

Primary Outcome Measures

Name	Time	Method
Value of Procalcitonin	February-April 2020	Value of Procalcitonin in each group (Meningioma Group, Glioma Group and Brain metastasis group)
Value of C-Reactive Protein	April- June 2020	Value of C-Reactive Protein in each group (Meningioma Group, Glioma Group and Brain metastasis group)
Value of Neutrophyl to Lymphocyte Ratio (NLR)	June- August 2020	Value of NLR in each group (Meningioma Group, Glioma Group and Brain metastasis group)

Secondary Outcome Measures

Name	Time	Method
Demographic of samples	August- October 2020	Demographic of each samples such as age, gender, Glassgow coma scale and Karnofsky score

Trial Locations

Locations (1)

Faculty of Medicine Universitas Sumatera Utara; 🇮🇩 Medan, North Sumatera, Indonesia