Gastrointestinal DiseasesESPRESSONCT06371820
ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden)
An observational study of Gastrointestinal Diseases, run by Karolinska Institutet.
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. Read more about this study
- Who is it for?
- Ages 0 to 110 years
- Conditions the study is for
- Gastrointestinal Diseases
- How many people
- 13,000,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1965to 17 May 2043
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 110 years
- All sexes
- Child, Adult, Older adult
Study population: Males 45.8% Median age at biopsy: 58 years
Who may be able to join
- 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.
Who cannot join
- -None
- (this is a registry-based study)
About this study
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/
Read the 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.
- Conditions
- Gastrointestinal Diseases
- Being tested
- ESPRESSO [The study has no intervention]
- Keywords
- cohort, gallbladder, gut, liver, pancreas, population-based, colon, pathology, endoscopy, celiac, inflammatory bowel disease, colitis, esophagus
- Medical subject headings
- Gastrointestinal Diseases, Celiac Disease, Inflammatory Bowel Diseases, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPRESSO [The study has no intervention]Other
This study has no interventions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident Mortality [especially rates]
Record of death in the Swedish Cause of Death Register. Please note: Different sub-projects will have different primary outcomes.
Measured: Currently up until 2022
Secondary outcomes (4)
Incident Cancer
ICD (international classification of diseases) code in the Swedish nationwide cancer register.
Measured: Currently up until 2022
Incident Cardiovascular disease
ICD (international classification of diseases) code in the Swedish nationwide Patient Register, and where appropriate also the Cause of Death Register
Measured: Currently up until 2022
Incident Neurological disease
ICD (international classification of diseases) code in the Swedish nationwide Patient Register, and where appropriate also the Cause of Death Register
Measured: Currently up until 2022
Incident Autoimmune diseases
ICD (international classification of diseases) code in the Swedish nationwide Patient Register, and where appropriate also the Cause of Death Register
Measured: Currently up until 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jan 1965
- Primary completion17 May 2043 (estimated)
- Study completion17 May 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Prospective
- Enrolment
- 13,000,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonas Ludvigsson, Karolinska Institutet
- Investigators
- Jonas F Ludvigsson, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371820
- Sponsor's protocol ID
- 2014/1287-31/4
- Acronym
- ESPRESSO
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make individual participant data (IPD) available to other researchers. (such sharing is not consistent with the rules from the Swedish government agency: Statistics Sweden).
Publications
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.
PubMed 30679926
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden)
- ClinicalTrials.gov ID
- NCT06371820
- Acronym / sponsor ID
- ESPRESSO / 2014/1287-31/4
- Conditions
- Gastrointestinal Diseases
- Keywords
- cohort, gallbladder, gut, liver, pancreas, population-based, colon, pathology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 13,000,000 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 1965 (actual)
- Primary completion
- 17 May 2043 (estimated)
- Study completion
- 17 May 2043 (estimated)
- First posted
- 17 Apr 2024 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 110 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Males 45.8% Median age at biopsy: 58 years
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- -None
- (this is a registry-based study)
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 |
|---|---|---|
| ESPRESSO [The study has no intervention]This study has no interventions. | Other | – |
Primary outcome
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.
4 secondary outcomes
Incident Cancer
Time frame: Currently up until 2022
Incident Cardiovascular disease
Time frame: Currently up until 2022
Incident Neurological disease
Time frame: Currently up until 2022
Incident Autoimmune diseases
Time frame: Currently up until 2022
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Results publication: PubMed 30679926Ludvigsson 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.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available to other researchers. (such sharing is not consistent with the rules from the Swedish government agency: Statistics Sweden).
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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.
Jonas F Ludvigsson, MD, PhD principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Diseases, run by Karolinska Institutet.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Incident Mortality [especially rates] (time frame: Currently up until 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06371820, which also lists 1 linked publication.
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 17 Apr 2024.