Brain TumorNCT04634188
Role and Value of Inflammatory Markers in Brain Tumors : A Case Controlled Study
An observational study of Brain Tumor, run by Universitas Sumatera Utara at 1 site in Indonesia.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Procalcitonin
- How many people
- 35 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2020to 1 Oct 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Samples were collected from patients at Haji Adam Malik Hospital in Medan, Sample collection began in March - September 2020
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine Universitas Sumatera Utara
Medan, North Sumatera, 20155
About this study
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:
- 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
Exclusion criteria:
- 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
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
- Brain Tumor
- Being tested
- Procalcitonin
- Keywords
- Brain Tumor, Inflammation, Procalcitonin, CRP, NLR
- Medical subject headings
- Brain Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProcalcitoninDiagnostic test
Also called C-Reactive Protein (CRP), Neutrophyl to Lymphocyte Ratio (NLR)
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Procalcitonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of Procalcitonin
Value of Procalcitonin in each group (Meningioma Group, Glioma Group and Brain metastasis group)
Measured: February-April 2020
Value of C-Reactive Protein
Value of C-Reactive Protein in each group (Meningioma Group, Glioma Group and Brain metastasis group)
Measured: April- June 2020
Value of Neutrophyl to Lymphocyte Ratio (NLR)
Value of NLR in each group (Meningioma Group, Glioma Group and Brain metastasis group)
Measured: June- August 2020
Secondary outcomes (1)
Demographic of samples
Demographic of each samples such as age, gender, Glassgow coma scale and Karnofsky score
Measured: August- October 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Jan 2020
- Primary completion1 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ridha Dharmajaya, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634188
- Sponsor's protocol ID
- Universitas Sumatera Utara
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 12749651Quail DF, Joyce JA. Microenvironmental regulation of tumor progression and metastasis. Nat Med. 2013 Nov;19(11):1423-37. doi: 10.1038/nm.3394.
PubMed 24202395Engelhardt 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 28092374Deutschman 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 9781714Bambury 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 23780645Hatherill 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 10519716Michelson 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 27397086Sen 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 21920453Tracey 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 8280464D'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 1357073Voll 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 9389474Balkwill 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 11229684Mantovani A, Allavena P, Sica A, Balkwill F. Cancer-related inflammation. Nature. 2008 Jul 24;454(7203):436-44. doi: 10.1038/nature07205.
PubMed 18650914Conti 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 24281089Faria 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role and Value of Inflammatory Markers in Brain Tumors : A Case Controlled Study
- ClinicalTrials.gov ID
- NCT04634188
- Acronym / sponsor ID
- Universitas Sumatera Utara
- Conditions
- Brain Tumor
- Keywords
- Brain Tumor, Inflammation, Procalcitonin, CRP, NLR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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
Exclusion criteria:
- 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
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meningioma Group | – | Diagnostic Test: ProcalcitoninThis 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. |
| Glioma Group | – | Diagnostic Test: ProcalcitoninThis 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. |
| Brain Metastasis Group | – | Diagnostic Test: ProcalcitoninThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Samples were collected from patients at Haji Adam Malik Hospital in Medan, Sample collection began in March - September 2020
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProcalcitoninAlso: C-Reactive Protein (CRP), Neutrophyl to Lymphocyte Ratio (NLR)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 | Diagnostic test | Brain Metastasis Group, Glioma Group, Meningioma Group |
Primary outcome
Value of Procalcitonin
Time frame: February-April 2020
Value of Procalcitonin in each group (Meningioma Group, Glioma Group and Brain metastasis group)
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)
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)
1 secondary outcome
Demographic of samples
Time frame: August- October 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Background: PubMed 12749651Casado-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.
- Results publication: PubMed 24202395Quail DF, Joyce JA. Microenvironmental regulation of tumor progression and metastasis. Nat Med. 2013 Nov;19(11):1423-37. doi: 10.1038/nm.3394.
- Results publication: PubMed 28092374Engelhardt 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.
- Results publication: PubMed 9781714Deutschman 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.
- Results publication: PubMed 23780645Bambury 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.
- Results publication: PubMed 10519716Hatherill 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.
- Results publication: PubMed 27397086Michelson 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.
- Results publication: PubMed 21920453Sen 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.
- Results publication: PubMed 8280464Tracey 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.
- Results publication: PubMed 1357073D'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.
- Results publication: PubMed 9389474Voll 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.
- Results publication: PubMed 11229684Balkwill 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, run by Universitas Sumatera Utara at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of Procalcitonin (time frame: February-April 2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04634188, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.