ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden)

Gastrointestinal Diseases Clinical Trial

— ESPRESSO  

Official title:

ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06371820
• Other study ID #: 2014/1287-31/4
• Status: Active, not recruiting
• 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
• 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
• 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)

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

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