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

November 11, 2020 updated by: Ridha Dharmajaya, Universitas Sumatera Utara
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

35

Contacts and Locations

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

Study Locations

  • Indonesia
    • North Sumatera
      • Medan, North Sumatera, Indonesia, 20155
        • Faculty of Medicine Universitas Sumatera Utara

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samples were collected from patients at Haji Adam Malik Hospital in Medan, Sample collection began in March - September 2020

Description

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 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
Meningioma Group

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.
Diagnostic test: Procalcitonin
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
Other Names:
  • C-Reactive Protein (CRP)
  • Neutrophyl to Lymphocyte Ratio (NLR)
Glioma Group

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.
Diagnostic test: Procalcitonin
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
Other Names:
  • C-Reactive Protein (CRP)
  • Neutrophyl to Lymphocyte Ratio (NLR)
Brain Metastasis Group
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.
Diagnostic test: Procalcitonin
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
Other Names:
  • C-Reactive Protein (CRP)
  • Neutrophyl to Lymphocyte Ratio (NLR)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic of samples
Time Frame: August- October 2020
Demographic of each samples such as age, gender, Glassgow coma scale and Karnofsky score
August- October 2020

Collaborators and Investigators

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

Sponsor

Universitas Sumatera Utara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2020

Primary Completion (ACTUAL)

September 1, 2020

Study Completion (ACTUAL)

October 1, 2020

Study Registration Dates

First Submitted

November 11, 2020

First Submitted That Met QC Criteria

November 11, 2020

First Posted (ACTUAL)

November 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 11, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Universitas Sumatera Utara

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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