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Time of DeathNCT03845439

Estimate of the TSD Based on the Quantification of the Tau Protein in CSF

An observational study of Time of Death, run by University Hospital, Montpellier at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: The accurate estimation of the time of death is a challenge in forensic medicine, as the methods routinely used to assess the post-mortem interval (PMI) are far from being precise. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Time of Death
What is being tested?
Lumbar puncture
How many people
80 participants
Where
1 siteFrance
Study dates
1 Nov 2017to 30 Oct 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: patient undergoing a forensic autopsy

Who may be able to join

  • Adult cadavers whose time of death is precisely known

Who cannot join

  • Individuals with neurological disorders, head trauma or with unknown past medical history or cause of death

Trial locations and contacts

1 site in 1 country.

Pierre-Antoine PEYRON, MD contact

467338586 ext. 33

pa-peyron@chu-montpellier.fr

France1 site, 1 recruiting
  • PEYRON

    Montpellier, 34295

    Pierre-Antoine PEYRON, MD, 467338586 ext. 33, pa-peyron@chu-montpellier.fr

    Recruiting

Other trials in France

About this study

Official title: Estimate of the Time Since Death Based on the Post Mortem Quantification of the Tau Protein in the Cerebrospinal Fluid

Background: The accurate estimation of the time of death is a challenge in forensic medicine, as the methods routinely used to assess the post-mortem interval (PMI) are far from being precise. Recent developments in biochemical techniques may provide the opportunity to assist in more precise estimation of the time of death. The focus has been placed on the study of the biochemical profiles of closed compartment body fluids, as they are longer preserved than blood after death and subject to confined post-mortem chemical changes. Cerebrospinal fluid (CSF) has been considered as a suitable fluid to investigate these changes, as it is easy to sample and found in large amount.

Due to its closeness to the central nervous system (CNS), CSF is used in clinical settings for the diagnosis of various CNS disorders such as Alzheimer's disease, whose diagnosis is mainly based on the increase of the concentrations of Tau protein and its phosphorylated isoform (p-Tau) in CSF. A post mortem leakage of Tau into the CSF has also been shown, reflecting progressive neuronal death as in Alzheimer's disease. In this exploratory, cross-sectional study, we investigated Tau in post mortem CSF as a potential biomarker of the time of death.

Objectives: The main objective was to assess the correlation between the concentration of Tau in CSF and the PMI. The secondary objectives were (1) to determine the inter-individual variability of the concentration of Tau for a same PMI; (2) to determine the kinetics of this concentration over time in the same individual; (3) to determine the variability of this concentration according to the site of collection (lumbar vs. sub-occipital).

Read the detailed description

Background: The accurate estimation of the time of death is a challenge in forensic medicine, as the methods routinely used to assess the post-mortem interval (PMI) are far from being precise. Recent developments in biochemical techniques may provide the opportunity to assist in more precise estimation of the time of death. The focus has been placed on the study of the biochemical profiles of closed compartment body fluids, as they are longer preserved than blood after death and subject to confined post-mortem chemical changes. Cerebrospinal fluid (CSF) has been considered as a suitable fluid to investigate these changes, as it is easy to sample and found in large amount.

Due to its closeness to the central nervous system (CNS), CSF is used in clinical settings for the diagnosis of various CNS disorders such as Alzheimer's disease, whose diagnosis is mainly based on the increase of the concentrations of Tau protein and its phosphorylated isoform (p-Tau) in CSF. A post mortem leakage of Tau into the CSF has also been shown, reflecting progressive neuronal death as in Alzheimer's disease. In this exploratory, cross-sectional study, we investigated Tau in post mortem CSF as a potential biomarker of the time of death.

Objectives: The main objective was to assess the correlation between the concentration of Tau in CSF and the PMI. The secondary objectives were (1) to determine the inter-individual variability of the concentration of Tau for a same PMI; (2) to determine the kinetics of this concentration over time in the same individual; (3) to determine the variability of this concentration according to the site of collection (lumbar vs. sub-occipital).

Materials and methods: The study was reviewed and approved by the Ethics Committee of the University Hospital of Montpellier. Post mortem CSF samples were collected from 80 adult cadavers whose time of death was precisely known, at the mortuary of the University Hospital of Montpellier. Individuals with neurological disorders and head trauma were excluded from the study, as well as subjects with unknown past medical history or cause of death. CSF samples were removed by cisternal and lumbar punctures at the time of arrival at the mortuary, before refrigeration. A few mL of CSF were obtained at each tap in clean, sterile polypropylene tubes, using a 18G lumbar puncture needle. The cadavers were divided into four groups according to the PMI (n=25 in each group). The samples were taken 0-6 h (group A), 6-12 h (group B), 12-18 h (group C) and 18-24 h (group D) after death. Additionally, CSF samples were collected every 3h from 10 cadavers during the first 15 h post mortem. All cadavers were kept at room temperature (+20 ± 2°C) during sample collection. CSF samples were transferred at +4°C to the laboratory where they were centrifuged for 10 min (+4°C, 1000 g). The clear supernatant was divided into aliquots then stored at -80°C until analysis. The rectal and tympanic temperatures were measured at the time of CSF collection using a probe thermometer.

Concentrations of Tau and and its phosphorylated isoform (p-Tau) were measured by conventional immunoassays, while total protein concentration was determined using a bicinchoninic acid protein assay.

The correlation coefficient between the concentration of Tau in CSF and the PMI was calculated in each case. The inter-individual variability was assessed by measuring the standard deviation (SD) of the mean concentration of Tau in each group. Linear regression analysis (adjusted for confounders) was used in assessing whether Tau concentration was dependent on the PMI. Paired Student's t-test was used to assess the variability of Tau concentration depending on the site of CSF collection

Conditions
Time of Death
Being tested
Lumbar puncture
Keywords
tau, post mortem interval, cerebrospinal fluid, immunoassay, biomarker, forensic medicine
Medical subject headings
Pick Disease of the Brain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lumbar punctureOther

    Lumbar puncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tau concentration in CSF

    Tau concentration in CSF

    Measured: 1 day

Secondary outcomes (1)
  1. pTau concentration in CSF

    pTau concentration in CSF

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2019
  2. Study start1 Nov 2017
  3. Primary completion1 Oct 2019 (estimated)
  4. Study completion30 Oct 2019 (estimated)

Resources

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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03845439
Sponsor's protocol ID
RECHMPL17_0369-Uf5003
Status last verified
Jan 2019
First submitted
18 Feb 2019
Last updated
19 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Time of Death, run by University Hospital, Montpellier at 1 site in France.

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: status not confirmed, as of the sponsor's last update on 19 Feb 2019. 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 France. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pierre-Antoine PEYRON, MD (467338586 ext. 33, pa-peyron@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tau concentration in CSF (time frame: 1 day). 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 19 Feb 2019.

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