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Active, Not Recruiting

NCT Number: NCT06371820

ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden)

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/

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ESPRESSO [The study has no intervention]

Other

This study has no interventions.

Primary outcomes

  1. Incident Mortality [especially rates]

    Time frame: Currently up until 2022

    Record of death in the Swedish Cause of Death Register. Please note: Different sub-projects will have different primary outcomes.

Secondary outcomes

  1. Incident Cancer

    Time frame: Currently up until 2022

    ICD (international classification of diseases) code in the Swedish nationwide cancer register.

  2. Incident Cardiovascular disease

    Time frame: Currently up until 2022

    ICD (international classification of diseases) code in the Swedish nationwide Patient Register, and where appropriate also the Cause of Death Register

  3. Incident Neurological disease

    Time frame: Currently up until 2022

    ICD (international classification of diseases) code in the Swedish nationwide Patient Register, and where appropriate also the Cause of Death Register

  4. Incident Autoimmune diseases

    Time frame: Currently up until 2022

    ICD (international classification of diseases) code in the Swedish nationwide Patient Register, and where appropriate also the Cause of Death Register

Other outcomes

  1. Please note that the recorded outcomes above are examples. Other outcomes may also be studied.

    Time frame: Currently up until 2022

    ICD codes as above

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Acronym: ESPRESSO

Important dates

Study start
1965
Primary completion
2043
Study completion
2043
First posted
Apr 17, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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