TumorNCT04501315
S100B in Intensive Care Patients With and Without Traumatic Brain Injury
An observational study of Tumor and Brain Injuries, run by University of Erlangen-Nürnberg Medical School.
Trial summary
The neurotrophic protein S100B has been promoted as a neuromarker for decades, and to reflect the severity of brain injury. On the other hand, S100B is a tumor marker. The interpretation of its serum levels may be altered by a contribution from extracerebral sources and its renal elimination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Brain Injuries, Trauma Injury
- What is being tested?
- Blood, cerebrospinal fluid and urine samples
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2007to 30 Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the Department of Neurosurgery, University of Erlangen-Nuremberg,
Who may be able to join
- patients of the Department of Neurosurgery, University of Erlangen Nürnberg, patients with traumatic brain injury,
- patients with intracranial tumor,
- intensive care patients,
- informed written consent was given by the Patient or the next of kin in each case.
Who cannot join
- age under 18
- pregnancy
About this study
Official title: S100B in Intensive Care Patients With and Without Traumatic Brain Injury: Implications for Neuromarker Assessment
The neurotrophic protein S100B has been promoted as a neuromarker for decades, and to reflect the severity of brain injury. On the other hand, S100B is a tumor marker. The interpretation of its serum levels may be altered by a contribution from extracerebral sources and its renal elimination.
In the present study we investigate the relevance of S100B as a prognostic factor, as well as the correlation with different CT classifications in a large cohort of patients with and without brain injury. Furthermore, we examine whether S100B is elevated in brain tumors.
Read the detailed description
Patients of the Department of Neurosurgery, University of Erlangen-Nuremberg, undergoing surgery for sellar lesions were prospectively included. The study protocol was approved by the local Ethical Committee. Informed written consent was given by the participants or the next-of-kin in each case. Exclusion criteria comprised of those below 18 years of age, pregnancy and a drug intolerance.
Patients baseline information included age, gender, clinical presentation, and preexisting medical conditions. In four different cohorts of patients, S100B was measured:
- ICU TBI, patients treated on the ICU with brain injury
- ICU tumor, patients treated on the ICU because of an intracranial tumor
- ICU surgery, patients treated on the ICU following surgery without brain injury
- ICU control, patients treated on the ICU without TBI, tumor or surgery
The performed diagnostic tests included blood, cerebrospinal fluid and urine samples. In all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM.
Samples were immediately centrifuged for 10min at 1.300xG and 4°C and stored at a temperature of -80°C until the assays were performed. Analysis was performed with commercially available kits on automated immunoanalyzers (LIAISON® Sangtec®100 by chemiluminescence immunoassay, Diasorin). The sensitivity of the assay was 0.02ng/ml.
In all cohorts the clinical status was documented with Glasgow Coma Score (GCS), and the outcome was assessed applying the Glasgow Outcome Score (GOS) or the Karnofsky Status Scale. The radiological work-up included a computed tomography (CT) or a magnetic resonance imaging (MRI). In brain injured patients, the CT was classifiied by the Marshall and Rotterdam Score. Extracranial injuries or surgical procedures were documented
Statistical analysis was performed with SPSS, and p<0.05 was accepted as significant.
- Conditions
- Tumor, Brain Injuries, Trauma Injury, Critical Illness, Surgery--Complications
- Being tested
- Blood, cerebrospinal fluid and urine samples
- Keywords
- S100B, biomarker, CT-classification, outcome, histology
- Medical subject headings
- Neoplasms, Brain Injuries, Accidental Injuries, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood, cerebrospinal fluid and urine samplesDiagnostic test
In all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM.
| Study group | Role | What they receive |
|---|---|---|
| ICU TBI | Patients treated on the ICU with brain injury Receives: Diagnostic Test: Blood, cerebrospinal fluid and urine samples | |
| ICU tumor | Patients treated on the ICU because of intracranial tumor Receives: Diagnostic Test: Blood, cerebrospinal fluid and urine samples | |
| ICU surgery | Patients treated on the ICU following surgery without brain injury Receives: Diagnostic Test: Blood, cerebrospinal fluid and urine samples | |
| ICU control | Patients treated on the ICU without TBI, tumor or surgery Receives: Diagnostic Test: Blood, cerebrospinal fluid and urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glascow Outcome Score (GOS)
The Glascow Outcome Scale classifies patients by objective degree of recovery, Minimum 1: death - Maximum 5: good recovery
Measured: up to one year post admission
Karnofsky Performance Status Score
Karnofsky Performance Status Scale describes patients functional status as a comprehensive 11 point scale correlatig to percentage values ranging from 100% ( no evidence of disease, no symptoms) to 0% ( death)
Measured: up to one year post admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Jul 2007
- Primary completion31 Dec 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Kleindienst, MD, PhD, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501315
- Sponsor's protocol ID
- S100B ICU
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S100B in Intensive Care Patients With and Without Traumatic Brain Injury: Implications for Neuromarker Assessment
- ClinicalTrials.gov ID
- NCT04501315
- Acronym / sponsor ID
- S100B ICU
- Conditions
- Tumor, Brain Injuries, Trauma Injury, Critical Illness, Surgery--Complications
- Keywords
- S100B, biomarker, CT-classification, outcome, histology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Jul 2007 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 6 Aug 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.
The neurotrophic protein S100B has been promoted as a neuromarker for decades, and to reflect the severity of brain injury. On the other hand, S100B is a tumor marker. The interpretation of its serum levels may be altered by a contribution from extracerebral sources and its renal elimination.
In the present study we investigate the relevance of S100B as a prognostic factor, as well as the correlation with different CT classifications in a large cohort of patients with and without brain injury. Furthermore, we examine whether S100B is elevated in brain tumors.
Detailed description
Patients of the Department of Neurosurgery, University of Erlangen-Nuremberg, undergoing surgery for sellar lesions were prospectively included. The study protocol was approved by the local Ethical Committee. Informed written consent was given by the participants or the next-of-kin in each case. Exclusion criteria comprised of those below 18 years of age, pregnancy and a drug intolerance.
Patients baseline information included age, gender, clinical presentation, and preexisting medical conditions. In four different cohorts of patients, S100B was measured:
- ICU TBI, patients treated on the ICU with brain injury
- ICU tumor, patients treated on the ICU because of an intracranial tumor
- ICU surgery, patients treated on the ICU following surgery without brain injury
- ICU control, patients treated on the ICU without TBI, tumor or surgery
The performed diagnostic tests included blood, cerebrospinal fluid and urine samples. In all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM.
Samples were immediately centrifuged for 10min at 1.300xG and 4°C and stored at a temperature of -80°C until the assays were performed. Analysis was performed with commercially available kits on automated immunoanalyzers (LIAISON® Sangtec®100 by chemiluminescence immunoassay, Diasorin). The sensitivity of the assay was 0.02ng/ml.
In all cohorts the clinical status was documented with Glasgow Coma Score (GCS), and the outcome was assessed applying the Glasgow Outcome Score (GOS) or the Karnofsky Status Scale. The radiological work-up included a computed tomography (CT) or a magnetic resonance imaging (MRI). In brain injured patients, the CT was classifiied by the Marshall and Rotterdam Score. Extracranial injuries or surgical procedures were documented
Statistical analysis was performed with SPSS, and p<0.05 was accepted as significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICU TBI | – | Diagnostic Test: Blood, cerebrospinal fluid and urine samplesPatients treated on the ICU with brain injury |
| ICU tumor | – | Diagnostic Test: Blood, cerebrospinal fluid and urine samplesPatients treated on the ICU because of intracranial tumor |
| ICU surgery | – | Diagnostic Test: Blood, cerebrospinal fluid and urine samplesPatients treated on the ICU following surgery without brain injury |
| ICU control | – | Diagnostic Test: Blood, cerebrospinal fluid and urine samplesPatients treated on the ICU without TBI, tumor or surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Department of Neurosurgery, University of Erlangen-Nuremberg,
Key inclusion criteria (4 listed)
- patients of the Department of Neurosurgery, University of Erlangen Nürnberg, patients with traumatic brain injury,
- patients with intracranial tumor,
- intensive care patients,
- informed written consent was given by the Patient or the next of kin in each case.
Key exclusion criteria (2 listed)
- age under 18
- pregnancy
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 |
|---|---|---|
| Blood, cerebrospinal fluid and urine samplesIn all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM. | Diagnostic test | ICU TBI, ICU control, ICU surgery, ICU tumor |
Primary outcome
Glascow Outcome Score (GOS)
Time frame: up to one year post admission
The Glascow Outcome Scale classifies patients by objective degree of recovery, Minimum 1: death - Maximum 5: good recovery
Karnofsky Performance Status Score
Time frame: up to one year post admission
Karnofsky Performance Status Scale describes patients functional status as a comprehensive 11 point scale correlatig to percentage values ranging from 100% ( no evidence of disease, no symptoms) to 0% ( death)
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 6 Aug 2020.
Related trials for Tumor
RecruitingPhase 1
A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors
Solid Tumor
RecruitingPhase 1
A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers
Lymphoma, Non-Hodgkin's, Lymphoma, Diffuse Large B-Cell
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Breast Cancer
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor and Brain Injuries, run by University of Erlangen-Nürnberg Medical School.
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 4 inclusion and 2 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 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Glascow Outcome Score (GOS) (time frame: up to one year post admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2020.