AutopsyECLAIRNCT07769801
Comparative Study of Clinical Diagnoses and Autopsy Findings in Intensive Care
An observational study of Autopsy and Autopsy in Intensive Care Unit, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The objective of this observational study is to compare clinical diagnoses with autopsy and anatomopathological reports of patients who died in the intensive care units of the Nancy University Hospital and the Metz-Thionville Regional Hospital since 2008. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autopsy, Autopsy in Intensive Care Unit
- What is being tested?
- Autopsy
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2025to 1 Mar 2026
- 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: Systematic recruitment of all patients who died since 2008 at the Nancy University Hospital and the Metz-Thionville Regional Hospital, who had been hospitalized in an intensive care unit and underwent a medico-scientific autopsy.
Who may be able to join
- Inclusion of all adult patients who died since 2008 in a department of the Metz-Thionville Regional Hospital or the Nancy University Hospital, who had been admitted to an intensive care unit during the same hospital stay, and who underwent a medico-scientific autopsy followed by an anatomopathological analysis.
Who cannot join
- Minor patients
- Patients who were not admitted to intensive care
- Forensic autopsies
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this observational study is to compare clinical diagnoses with autopsy and anatomopathological reports of patients who died in the intensive care units of the Nancy University Hospital and the Metz-Thionville Regional Hospital since 2008. This would highlight diagnostic discrepancies that could have influenced patient management and help redefine the role and importance of autopsy in this population.
- Conditions
- Autopsy, Autopsy in Intensive Care Unit
- Being tested
- Autopsy
- Keywords
- Autopsy, Intensive Care, Cause of death, Discrepancy, Diagnostic error, Missed diagnosis, Adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutopsyDiagnostic test
Also called anatomopathological reports
Autopsy realised in adult patients during of after a hospitalization in an intensive care unit.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Diagnostic Discrepancies (Goldman Class I and II) between Clinical and Autopsy Diagnoses
Proportion of autopsied ICU patients with a major diagnostic discrepancy (Goldman class I or II) between the antemortem clinical diagnosis and the post-mortem autopsy diagnosis, classified according to the Goldman classification
Measured: Diagnoses assessed at time of autopsy, for patients who died in ICU between January 1, 2008 and December 31, 2025
Secondary outcomes (4)
Type and anatomical/etiological category of diagnoses missed clinically and identified at autopsy (Goldman Class I-IV)
Distribution of missed diagnoses by organ system and etiological category (infectious, vascular, neoplastic, etc.) among discrepancies classified as Goldman class I to IV.
Measured: Diagnoses assessed at time of autopsy, for patients who died in ICU between January 1, 2008 and December 31, 2025
Odds Ratios for Patient and Clinical Characteristics Associated With Major Diagnostic Discrepancy (Goldman Class I/II)
Association between diagnostic discrepancy status (Goldman class I/II vs. class III-VI) and pre-specified patient/clinical characteristics - including age, sex, immunosuppression status, indication for hospitalization, duration of hospital and ICU stay, admission unit, SAPS II score, type of organ failure, presence of septic shock, use of mechanical ventilation, renal replacement therapy, ECMO support, immunosuppressive therapy, and imaging modality - assessed by univariable and multivariable logistic regression, expressed as odds ratios with 95% confidence intervals.
Measured: Assessed using clinical data collected from ICU admission to death, for patients who died and underwent autopsy between January 1, 2008 and December 31, 2025
Autopsy Rate Among ICU Deaths
Proportion of ICU deaths for which an autopsy was performed, calculated as the number of autopsies divided by the total number of deaths occurring after ICU admission, expressed as a percentage
Measured: Calculated over the entire study period, from January 1, 2008 to December 31, 2025
Concordance Rate Between Antemortem Imaging Findings and Autopsy/Pathology Findings
Proportion of cases in which findings from the last antemortem imaging examination (CT, MRI, or ultrasound) performed before death are concordant with autopsy and/or anatomopathological findings. Concordance was assessed qualitatively by investigator review of imaging reports compared with autopsy/pathology reports, and classified as concordant, partially concordant, or discordant, without use of a standardized scoring system.
Measured: Assessed at time of autopsy report, for patients who underwent both antemortem imaging and autopsy between January 1, 2008 and December 31, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 May 2025
- Primary completion31 Dec 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutopsyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Central Hospital, Metz Thionville, France
- Responsible party
- Principal investigator, Guillaume GAUCHOTTE, Central Hospital, Nancy, France
- Investigators
- Guillaume Louis, MD, Principal investigator, Central Hospital, Metz Thionville, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769801
- Sponsor's protocol ID
- 2024PI170
- Acronym
- ECLAIR
- Status last verified
- Aug 2026
- First submitted
- 17 Apr 2026
- Last updated
- 18 Aug 2026
- 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Clinical Diagnoses and Autopsy Findings in Intensive Care
- ClinicalTrials.gov ID
- NCT07769801
- Acronym / sponsor ID
- ECLAIR / 2024PI170
- Conditions
- Autopsy, Autopsy in Intensive Care Unit
- Keywords
- Autopsy, Intensive Care, Cause of death, Discrepancy, Diagnostic error, Missed diagnosis, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Central Hospital, Metz Thionville, France
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 18 Aug 2026 (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 objective of this observational study is to compare clinical diagnoses with autopsy and anatomopathological reports of patients who died in the intensive care units of the Nancy University Hospital and the Metz-Thionville Regional Hospital since 2008. This would highlight diagnostic discrepancies that could have influenced patient management and help redefine the role and importance of autopsy in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Systematic recruitment of all patients who died since 2008 at the Nancy University Hospital and the Metz-Thionville Regional Hospital, who had been hospitalized in an intensive care unit and underwent a medico-scientific autopsy.
Key inclusion criteria (1 listed)
- Inclusion of all adult patients who died since 2008 in a department of the Metz-Thionville Regional Hospital or the Nancy University Hospital, who had been admitted to an intensive care unit during the same hospital stay, and who underwent a medico-scientific autopsy followed by an anatomopathological analysis.
Key exclusion criteria (3 listed)
- Minor patients
- Patients who were not admitted to intensive care
- Forensic autopsies
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 |
|---|---|---|
| AutopsyAlso: anatomopathological reportsAutopsy realised in adult patients during of after a hospitalization in an intensive care unit. | Diagnostic test | – |
Primary outcome
Rate of Major Diagnostic Discrepancies (Goldman Class I and II) between Clinical and Autopsy Diagnoses
Time frame: Diagnoses assessed at time of autopsy, for patients who died in ICU between January 1, 2008 and December 31, 2025
Proportion of autopsied ICU patients with a major diagnostic discrepancy (Goldman class I or II) between the antemortem clinical diagnosis and the post-mortem autopsy diagnosis, classified according to the Goldman classification
4 secondary outcomes
Type and anatomical/etiological category of diagnoses missed clinically and identified at autopsy (Goldman Class I-IV)
Time frame: Diagnoses assessed at time of autopsy, for patients who died in ICU between January 1, 2008 and December 31, 2025
Odds Ratios for Patient and Clinical Characteristics Associated With Major Diagnostic Discrepancy (Goldman Class I/II)
Time frame: Assessed using clinical data collected from ICU admission to death, for patients who died and underwent autopsy between January 1, 2008 and December 31, 2025
Autopsy Rate Among ICU Deaths
Time frame: Calculated over the entire study period, from January 1, 2008 to December 31, 2025
Concordance Rate Between Antemortem Imaging Findings and Autopsy/Pathology Findings
Time frame: Assessed at time of autopsy report, for patients who underwent both antemortem imaging and autopsy between January 1, 2008 and December 31, 2025
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 Aug 2026.
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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.
Guillaume Louis, MD principal investigator
Central Hospital, Metz Thionville, France
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 Autopsy and Autopsy in Intensive Care Unit, run by Central Hospital, Nancy, France 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 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 Aug 2026. 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?
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?
Rate of Major Diagnostic Discrepancies (Goldman Class I and II) between Clinical and Autopsy Diagnoses (time frame: Diagnoses assessed at time of autopsy, for patients who died in ICU between January 1, 2008 and December 31, 2025). 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 18 Aug 2026.