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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06371820
Other study ID # 2014/1287-31/4
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 1965
Est. completion date May 17, 2043

Study information

Verified date April 2024
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The ESPRESSO study is a collection of data from all computerised gastrointestinal histopathology reports in Sweden. This allows us to study risk factors for gastrointestinal disease, as well as the prognosis of gastrointestinal disease. A review of the study has been published here: https://pubmed.ncbi.nlm.nih.gov/30679926/


Description:

The ESPRESSO study constitutes a novel approach to examine the etiology and prognosis of gastrointestinal disease in which histopathology plays a prominent role. Between 2015 and 2017, all pathology departments (n=28) in Sweden were contacted and asked to procure histopathology record data from the gastrointestinal tract (pharynx to anus), liver, gallbladder, and pancreas. For each individual, local histopathology IT personnel retrieved data on personal identity number, date of histopathology, topography (where the biopsy is taken), morphology (biopsy appearance), and where available free text. In total, between 1965 and 2017, histopathology record data were available in 2.1 million unique individuals, but the number of data entries was 6.1 million because more than one biopsy was performed in many of the study participants. Index individuals with histopathology data were matched with up to five controls from the general population. The investigators also identified all first-degree relatives (parents, children, full siblings), and the index individual's first spouse. The total study population consisted of 13.0 million individuals. Data from all the study participants have been linked to Swedish National Healthcare Registers allowing research not only on such aspects as fetal and perinatal conditions and the risk of future gastrointestinal disease but also on the risk of comorbidity and complications (including cancer and death). Furthermore, the ESPRESSO database allows researchers and practitioners to identify diagnoses and disease phenotypes not currently indexed in national registers (including disease precursors). The ESPRESSO database increases the sensitivity and specificity of already-recorded diseases in the national health registers. This paper is an overview of the ESPRESSO database.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 13000000
Est. completion date May 17, 2043
Est. primary completion date May 17, 2043
Accepts healthy volunteers
Gender All
Age group 0 Years to 110 Years
Eligibility Inclusion Criteria: - Any person with a computerised histopathology record from the gastrointestinal tract including the liver, gallbladder and the pancreas. - Matched controls to any person with the above histopathology record. - Spouses and first-degree relatives to any of the above. Exclusion Criteria: -None (this is a registry-based study)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ESPRESSO [The study has no intervention]
This study has no interventions.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

References & Publications (1)

Ludvigsson JF, Lashkariani M. Cohort profile: ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden). Clin Epidemiol. 2019 Jan 14;11:101-114. doi: 10.2147/CLEP.S191914. eCollection 2019. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Please note that the recorded outcomes above are examples. Other outcomes may also be studied. ICD codes as above Currently up until 2022
Primary Incident Mortality [especially rates] Record of death in the Swedish Cause of Death Register. Please note: Different sub-projects will have different primary outcomes. Currently up until 2022
Secondary Incident Cancer ICD (international classification of diseases) code in the Swedish nationwide cancer register. Currently up until 2022
Secondary Incident Cardiovascular disease ICD (international classification of diseases) code in the Swedish nationwide Patient Register, and where appropriate also the Cause of Death Register Currently up until 2022
Secondary Incident Neurological disease ICD (international classification of diseases) code in the Swedish nationwide Patient Register, and where appropriate also the Cause of Death Register Currently up until 2022
Secondary Incident Autoimmune diseases ICD (international classification of diseases) code in the Swedish nationwide Patient Register, and where appropriate also the Cause of Death Register Currently up until 2022
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