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

NCT ID: NCT04634188

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Tumor

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Brain Tumor, Inflammation, Procalcitonin, CRP, NLR

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Procalcitonin

Intervention Type DIAGNOSTIC_TEST

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

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.

Procalcitonin

Intervention Type DIAGNOSTIC_TEST

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

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.

Procalcitonin

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

C-Reactive Protein (CRP) Neutrophyl to Lymphocyte Ratio (NLR)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitas Sumatera Utara

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ridha Dharmajaya

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine Universitas Sumatera Utara

Medan, North Sumatera, Indonesia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

References

Explore related publications, articles, or registry entries linked to this study.

Casado-Flores J, Blanco-Quiros A, Asensio J, Arranz E, Garrote JA, Nieto M. Serum procalcitonin in children with suspected sepsis: a comparison with C-reactive protein and neutrophil count. Pediatr Crit Care Med. 2003 Apr;4(2):190-5. doi: 10.1097/01.PCC.0000059420.15811.2D.

Reference Type BACKGROUND
PMID: 12749651 (View on PubMed)

Quail DF, Joyce JA. Microenvironmental regulation of tumor progression and metastasis. Nat Med. 2013 Nov;19(11):1423-37. doi: 10.1038/nm.3394.

Reference Type RESULT
PMID: 24202395 (View on PubMed)

Engelhardt B, Vajkoczy P, Weller RO. The movers and shapers in immune privilege of the CNS. Nat Immunol. 2017 Feb;18(2):123-131. doi: 10.1038/ni.3666. Epub 2017 Jan 16.

Reference Type RESULT
PMID: 28092374 (View on PubMed)

Deutschman CS. Acute-phase responses and SIRS/MODS: the good, the bad, and the nebulous. Crit Care Med. 1998 Oct;26(10):1630-1. doi: 10.1097/00003246-199810000-00007. No abstract available.

Reference Type RESULT
PMID: 9781714 (View on PubMed)

Bambury RM, Teo MY, Power DG, Yusuf A, Murray S, Battley JE, Drake C, O'Dea P, Bermingham N, Keohane C, Grossman SA, Moylan EJ, O'Reilly S. The association of pre-treatment neutrophil to lymphocyte ratio with overall survival in patients with glioblastoma multiforme. J Neurooncol. 2013 Aug;114(1):149-54. doi: 10.1007/s11060-013-1164-9. Epub 2013 Jun 19.

Reference Type RESULT
PMID: 23780645 (View on PubMed)

Hatherill M, Tibby SM, Sykes K, Turner C, Murdoch IA. Diagnostic markers of infection: comparison of procalcitonin with C reactive protein and leucocyte count. Arch Dis Child. 1999 Nov;81(5):417-21. doi: 10.1136/adc.81.5.417.

Reference Type RESULT
PMID: 10519716 (View on PubMed)

Michelson N, Rincon-Torroella J, Quinones-Hinojosa A, Greenfield JP. Exploring the role of inflammation in the malignant transformation of low-grade gliomas. J Neuroimmunol. 2016 Aug 15;297:132-40. doi: 10.1016/j.jneuroim.2016.05.019. Epub 2016 May 25.

Reference Type RESULT
PMID: 27397086 (View on PubMed)

Sen E. Targeting inflammation-induced transcription factor activation: an open frontier for glioma therapy. Drug Discov Today. 2011 Dec;16(23-24):1044-51. doi: 10.1016/j.drudis.2011.09.003. Epub 2011 Sep 6.

Reference Type RESULT
PMID: 21920453 (View on PubMed)

Tracey KJ, Cerami A. Tumor necrosis factor, other cytokines and disease. Annu Rev Cell Biol. 1993;9:317-43. doi: 10.1146/annurev.cb.09.110193.001533. No abstract available.

Reference Type RESULT
PMID: 8280464 (View on PubMed)

D'Andrea A, Rengaraju M, Valiante NM, Chehimi J, Kubin M, Aste M, Chan SH, Kobayashi M, Young D, Nickbarg E, et al. Production of natural killer cell stimulatory factor (interleukin 12) by peripheral blood mononuclear cells. J Exp Med. 1992 Nov 1;176(5):1387-98. doi: 10.1084/jem.176.5.1387.

Reference Type RESULT
PMID: 1357073 (View on PubMed)

Voll RE, Herrmann M, Roth EA, Stach C, Kalden JR, Girkontaite I. Immunosuppressive effects of apoptotic cells. Nature. 1997 Nov 27;390(6658):350-1. doi: 10.1038/37022. No abstract available.

Reference Type RESULT
PMID: 9389474 (View on PubMed)

Balkwill F, Mantovani A. Inflammation and cancer: back to Virchow? Lancet. 2001 Feb 17;357(9255):539-45. doi: 10.1016/S0140-6736(00)04046-0.

Reference Type RESULT
PMID: 11229684 (View on PubMed)

Mantovani A, Allavena P, Sica A, Balkwill F. Cancer-related inflammation. Nature. 2008 Jul 24;454(7203):436-44. doi: 10.1038/nature07205.

Reference Type RESULT
PMID: 18650914 (View on PubMed)

Conti A, Guli C, La Torre D, Tomasello C, Angileri FF, Aguennouz M. Role of inflammation and oxidative stress mediators in gliomas. Cancers (Basel). 2010 Apr 26;2(2):693-712. doi: 10.3390/cancers2020693.

Reference Type RESULT
PMID: 24281089 (View on PubMed)

Faria SS, Fernandes PC Jr, Silva MJ, Lima VC, Fontes W, Freitas-Junior R, Eterovic AK, Forget P. The neutrophil-to-lymphocyte ratio: a narrative review. Ecancermedicalscience. 2016 Dec 12;10:702. doi: 10.3332/ecancer.2016.702. eCollection 2016.

Reference Type RESULT
PMID: 28105073 (View on PubMed)

Templeton AJ, Ace O, McNamara MG, Al-Mubarak M, Vera-Badillo FE, Hermanns T, Seruga B, Ocana A, Tannock IF, Amir E. Prognostic role of platelet to lymphocyte ratio in solid tumors: a systematic review and meta-analysis. Cancer Epidemiol Biomarkers Prev. 2014 Jul;23(7):1204-12. doi: 10.1158/1055-9965.EPI-14-0146. Epub 2014 May 3.

Reference Type RESULT
PMID: 24793958 (View on PubMed)

Zadora P, Dabrowski W, Czarko K, Smolen A, Kotlinska-Hasiec E, Wiorkowski K, Sikora A, Jarosz B, Kura K, Rola R, Trojanowski T. Preoperative neutrophil-lymphocyte count ratio helps predict the grade of glial tumor - a pilot study. Neurol Neurochir Pol. 2015;49(1):41-4. doi: 10.1016/j.pjnns.2014.12.006. Epub 2015 Jan 6.

Reference Type RESULT
PMID: 25666772 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Universitas Sumatera Utara

Identifier Type: -

Identifier Source: org_study_id