Amyotrophic Lateral SclerosisNCT02582385
In-situ Cytokines Expression in the CNS in Amyotrophic Lateral Sclerosis (ALS)
An observational study of Amyotrophic Lateral Sclerosis, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
The investigators aim at exploring the differential/topographical in-situ expression of cytokines in the central nervous system (CNS) of patients who died with amyotrophic lateral sclerosis (ALS), using archived histopathology slides and residual paraffin blocks from autopsied cases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- in-situ cytokine expression
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2012to Feb 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Archived/residual histopathology slides and paraffin blocks from residual autopsy material from patients who died with amyotrophic lateral sclerosis.
Who may be able to join
- patients who died with amyotrophic lateral sclerosis, having been autopsied.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In-situ Cytokines Expression in the CNS in Amyotrophic Lateral Sclerosis
The investigators aim at exploring the differential/topographical in-situ expression of cytokines in the central nervous system (CNS) of patients who died with amyotrophic lateral sclerosis (ALS), using archived histopathology slides and residual paraffin blocks from autopsied cases. Previous studies from the investigators and other groups showed that inflammatory cytokines are implicated in several neurological affections, particularly neurodegenerative conditions. However, in-situ cytokine expression has never been studied so far in ALS. The investigators wanted to see if these neuro-mediators are involved in the neuromolecular chain/cascade underlying ALS.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- in-situ cytokine expression
- Keywords
- Amyotrophic lateral sclerosis (ALS), Cytokines, Neuropathology
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-situ cytokine expressionOther
| Study group | Role | What they receive |
|---|---|---|
| Amyotrophic lateral sclerosis (ALS) | Archived/residual histopathology sections and paraffin blocks, retrieved entirely from residual autopsy material from patients who died with an amyotrophic lateral sclerosis. Receives: Other: in-situ cytokine expression | |
| Control | Archived/residual histopathology sections and paraffin blocks, retrieved entirely from residual autopsy material from one non-ALS case. Receives: Other: in-situ cytokine expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
in situ cytokine detection: interleukin 18
IHC detection on histopathology sections of paraffin embedded brain tissue.
Measured: retrospective study performed on archived paraffin blocks, autopsies performed between 2000 and 2005
in situ cytokine detection: interleukin 1
IHC detection on histopathology sections of paraffin embedded brain tissue.
Measured: retrospective study performed on archived paraffin blocks, autopsies performed between 2000 and 2005
in situ cytokine detection: interleukin 6
IHC detection on histopathology sections of paraffin embedded brain tissue.
Measured: retrospective study performed on archived paraffin blocks, autopsies performed between 2000 and 2005
in situ cytokine detection:TNF-a
IHC detection on histopathology sections of paraffin embedded brain tissue.
Measured: retrospective study performed on archived paraffin blocks, autopsies performed between 2000 and 2005
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies 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
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carine DE PREZ, Brugmann University Hospital
- Investigators
- Hazim Kadhim, MD, PhD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582385
- Sponsor's protocol ID
- CHUB-ALS
- Status last verified
- Oct 2015
- First submitted
- 20 Oct 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-situ Cytokines Expression in the CNS in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT02582385
- Acronym / sponsor ID
- CHUB-ALS
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic lateral sclerosis (ALS), Cytokines, Neuropathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Oct 2015 (estimated)
- 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 investigators aim at exploring the differential/topographical in-situ expression of cytokines in the central nervous system (CNS) of patients who died with amyotrophic lateral sclerosis (ALS), using archived histopathology slides and residual paraffin blocks from autopsied cases. Previous studies from the investigators and other groups showed that inflammatory cytokines are implicated in several neurological affections, particularly neurodegenerative conditions. However, in-situ cytokine expression has never been studied so far in ALS. The investigators wanted to see if these neuro-mediators are involved in the neuromolecular chain/cascade underlying ALS.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amyotrophic lateral sclerosis (ALS) | – | Other: in-situ cytokine expressionArchived/residual histopathology sections and paraffin blocks, retrieved entirely from residual autopsy material from patients who died with an amyotrophic lateral sclerosis. |
| Control | – | Other: in-situ cytokine expressionArchived/residual histopathology sections and paraffin blocks, retrieved entirely from residual autopsy material from one non-ALS case. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Archived/residual histopathology slides and paraffin blocks from residual autopsy material from patients who died with amyotrophic lateral sclerosis.
Key inclusion criteria (1 listed)
- patients who died with amyotrophic lateral sclerosis, having been autopsied.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| in-situ cytokine expression | Other | Amyotrophic lateral sclerosis (ALS), Control |
Primary outcome
in situ cytokine detection: interleukin 18
Time frame: retrospective study performed on archived paraffin blocks, autopsies performed between 2000 and 2005
IHC detection on histopathology sections of paraffin embedded brain tissue.
in situ cytokine detection: interleukin 1
Time frame: retrospective study performed on archived paraffin blocks, autopsies performed between 2000 and 2005
IHC detection on histopathology sections of paraffin embedded brain tissue.
in situ cytokine detection: interleukin 6
Time frame: retrospective study performed on archived paraffin blocks, autopsies performed between 2000 and 2005
IHC detection on histopathology sections of paraffin embedded brain tissue.
in situ cytokine detection:TNF-a
Time frame: retrospective study performed on archived paraffin blocks, autopsies performed between 2000 and 2005
IHC detection on histopathology sections of paraffin embedded brain tissue.
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 21 Oct 2015.
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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.
Hazim Kadhim, MD, PhD principal investigator
CHU Brugmann
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 Amyotrophic Lateral Sclerosis, run by Brugmann University Hospital at 1 site in Belgium.
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 1 inclusion and 1 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 21 Oct 2015. 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 Belgium. 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?
in situ cytokine detection: interleukin 18 (time frame: retrospective study performed on archived paraffin blocks, autopsies performed between 2000 and 2005). The study lists 4 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 21 Oct 2015.