NCT04634188

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

November 11, 2020

Last Update Submit

November 11, 2020

Conditions

Brain Tumor

Keywords

Brain Tumor, Inflammation, Procalcitonin, CRP, NLR

Outcome Measures

Primary Outcomes (3)

  • Value of Procalcitonin

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

    February-April 2020

  • Value of C-Reactive Protein

    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)

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

    June- August 2020

Secondary Outcomes (1)

  • Demographic of samples

    August- October 2020

Study Arms (3)

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

ProcalcitoninDIAGNOSTIC_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

Also known as: C-Reactive Protein (CRP), Neutrophyl to Lymphocyte Ratio (NLR)
Brain Metastasis GroupGlioma GroupMeningioma Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Universitas Sumatera Utara

Medan, North Sumatera, 20155, Indonesia

Location

Related Publications (17)

  • 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.

    PMID: 12749651BACKGROUND

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

    PMID: 24202395RESULT

  • 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.

    PMID: 28092374RESULT

  • 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.

    PMID: 9781714RESULT

  • 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.

    PMID: 23780645RESULT

  • 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.

    PMID: 10519716RESULT

  • 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.

    PMID: 27397086RESULT

  • 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.

    PMID: 21920453RESULT

  • 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.

    PMID: 8280464RESULT

  • 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.

    PMID: 1357073RESULT

  • 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.

    PMID: 9389474RESULT

  • 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.

    PMID: 11229684RESULT

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

    PMID: 18650914RESULT

  • 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.

    PMID: 24281089RESULT

  • 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.

    PMID: 28105073RESULT

  • 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.

    PMID: 24793958RESULT

  • 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.

    PMID: 25666772RESULT

MeSH Terms

Conditions

Brain NeoplasmsInflammation

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 11, 2020

First Posted

November 18, 2020

Study Start

January 1, 2020

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations

ID(1)