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CompletedNCT04634188Updated Nov 18, 2020

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

An observational study in Brain Tumor, sponsored by Universitas Sumatera Utara. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-18.

Sponsored by Universitas Sumatera Utara · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
35
Ages
18 Years to 70 Years
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Brain Tumor

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Keywords

  • Brain Tumor, Inflammation, Procalcitonin, CRP, NLR
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In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's enrollment of 35 is below the median of 100 across 380 observational studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Universitas Sumatera Utara is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

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

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
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
35 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • 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

  • 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

Interventions

  • Diagnostic testProcalcitonin

    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

    Also known as: C-Reactive Protein (CRP), Neutrophyl to Lymphocyte Ratio (NLR)

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What researchers measure

Primary outcomes

  1. Value of Procalcitonin

    Value of Procalcitonin in each group (Meningioma Group, Glioma Group and Brain metastasis group)

    Time frame: February-April 2020

  2. Value of C-Reactive Protein

    Value of C-Reactive Protein in each group (Meningioma Group, Glioma Group and Brain metastasis group)

    Time frame: April- June 2020

  3. Value of Neutrophyl to Lymphocyte Ratio (NLR)

    Value of NLR in each group (Meningioma Group, Glioma Group and Brain metastasis group)

    Time frame: June- August 2020

Secondary outcomes

  1. Demographic of samples

    Demographic of each samples such as age, gender, Glassgow coma scale and Karnofsky score

    Time frame: August- October 2020

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Study locations

1 site
  • Faculty of Medicine Universitas Sumatera Utara
    Medan, North Sumatera 20155, Indonesia
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References and documents

Publications

  • 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. PubMed 12749651 ↗
  • Quail DF, Joyce JA. Microenvironmental regulation of tumor progression and metastasis. Nat Med. 2013 Nov;19(11):1423-37. doi: 10.1038/nm.3394. PubMed 24202395 ↗
  • 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. PubMed 28092374 ↗
  • 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. PubMed 9781714 ↗
  • 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. PubMed 23780645 ↗
  • 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. PubMed 10519716 ↗
  • 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. PubMed 27397086 ↗
  • 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. PubMed 21920453 ↗
  • 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. PubMed 8280464 ↗
  • 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. PubMed 1357073 ↗
  • 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. PubMed 9389474 ↗
  • 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. PubMed 11229684 ↗
  • Mantovani A, Allavena P, Sica A, Balkwill F. Cancer-related inflammation. Nature. 2008 Jul 24;454(7203):436-44. doi: 10.1038/nature07205. PubMed 18650914 ↗
  • 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. PubMed 24281089 ↗
  • 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. PubMed 28105073 ↗
  • 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. PubMed 24793958 ↗
  • 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. PubMed 25666772 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04634188
Lead sponsor
Universitas Sumatera Utara
Responsible party
Ridha Dharmajaya (Prof. Dr., Universitas Sumatera Utara) — Principal investigator
First posted
Nov 18, 2020
Start date
Jan 1, 2020
Primary completion
Sep 1, 2020
Completion
Oct 1, 2020
Last update
Nov 18, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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