Clinical trial NCT06371820: ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden)
Official title: ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastrointestinal Diseases
Keywords: cohort
gallbladder
gut
liver
pancreas
population-based
colon
pathology
endoscopy
celiac
inflammatory bowel disease
colitis
esophagus
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 13000000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males 45.8% Median age at biopsy: 58 years

Brief 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/

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Incident Mortality [especially rates]
timeFrame: Currently up until 2022
Secondary outcomes:
measure: Incident Cancer
timeFrame: Currently up until 2022
measure: Incident Cardiovascular disease
timeFrame: Currently up until 2022
measure: Incident Neurological disease
timeFrame: Currently up until 2022
measure: Incident Autoimmune diseases
timeFrame: Currently up until 2022
Other outcomes:
measure: Please note that the recorded outcomes above are examples. Other outcomes may also be studied.
timeFrame: Currently up until 2022
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Jonas F Ludvigsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.