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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04634188
Other study ID # Universitas Sumatera Utara
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date October 1, 2020

Study information

Verified date November 2020
Source Universitas Sumatera Utara
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date October 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Indonesia Faculty of Medicine Universitas Sumatera Utara Medan North Sumatera

Sponsors (1)

Lead Sponsor Collaborator
Universitas Sumatera Utara

Country where clinical trial is conducted

Indonesia, 

References & Publications (17)

Balkwill F, Mantovani A. Inflammation and cancer: back to Virchow? Lancet. 2001 Feb 17;357(9255):539-45. Review. — View Citation

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 — View Citation

Casado-Flores J, Blanco-Quirós 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. — View Citation

Conti A, Gulì 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. — View Citation

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):1 — View Citation

Deutschman CS. Acute-phase responses and SIRS/MODS: the good, the bad, and the nebulous. Crit Care Med. 1998 Oct;26(10):1630-1. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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

Michelson N, Rincon-Torroella J, Quiñones-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. Re — View Citation

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

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. Review. — View Citation

Templeton AJ, Ace O, McNamara MG, Al-Mubarak M, Vera-Badillo FE, Hermanns T, Seruga B, Ocaña 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. 2 — View Citation

Tracey KJ, Cerami A. Tumor necrosis factor, other cytokines and disease. Annu Rev Cell Biol. 1993;9:317-43. Review. — View Citation

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. — View Citation

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. 20 — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Value of Procalcitonin Value of Procalcitonin in each group (Meningioma Group, Glioma Group and Brain metastasis group) February-April 2020
Primary Value of C-Reactive Protein Value of C-Reactive Protein in each group (Meningioma Group, Glioma Group and Brain metastasis group) April- June 2020
Primary 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 Demographic of samples Demographic of each samples such as age, gender, Glassgow coma scale and Karnofsky score August- October 2020
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