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In-situ Cytokines Expression in the CNS in Amyotrophic Lateral Sclerosis (ALS)

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ClinicalTrials.gov Identifier: NCT02582385
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Carine DE PREZ, Brugmann University Hospital

Tracking Information
First Submitted Date October 20, 2015
First Posted Date October 21, 2015
Last Update Posted Date October 21, 2015
Study Start Date October 2012
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 20, 2015)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title In-situ Cytokines Expression in the CNS in Amyotrophic Lateral Sclerosis (ALS)
Official Title In-situ Cytokines Expression in the CNS in Amyotrophic Lateral Sclerosis
Brief 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. 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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Archived/residual histopathology sections and paraffin blocks entirely from residual autopsy material. Archived material involves old cases (autopsied between 2000 and 2005). All autopsies were conducted within the legal frame of the then applicable laws. There is no reference whatsoever to names or identifications of the deceased patients (anonymous samples).
Sampling Method Non-Probability Sample
Study Population Archived/residual histopathology slides and paraffin blocks from residual autopsy material from patients who died with amyotrophic lateral sclerosis.
Condition Amyotrophic Lateral Sclerosis
Intervention Other: in-situ cytokine expression
Study Groups/Cohorts
  • 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.
    Intervention: Other: in-situ cytokine expression
  • Control
    Archived/residual histopathology sections and paraffin blocks, retrieved entirely from residual autopsy material from one non-ALS case.
    Intervention: Other: in-situ cytokine expression
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 20, 2015)
5
Original Actual Enrollment Same as current
Actual Study Completion Date February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients who died with amyotrophic lateral sclerosis, having been autopsied.

Exclusion Criteria:

  • N/A
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02582385
Other Study ID Numbers CHUB-ALS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Carine DE PREZ, Brugmann University Hospital
Study Sponsor Brugmann University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Hazim Kadhim, MD, PhD CHU Brugmann
PRS Account Brugmann University Hospital
Verification Date October 2015