Nordic Gastric and Esophageal Tumor Study

NCT05688761 | Completed

• 1 other identifier: NordGETS
• Study Type: observational
• Target: 900,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a population-based case-control study in all 5 Nordic countries from 1994 onwards. Cases with esophageal or gastric cancer will be compared with 10 times as many population controls. The project includes a specific study "Long-term medication with proton pump inhibitors and risk of gastric cancer", which is summarized here: Research question: Medication with proton pump inhibitors (PPI) is a most commonly used drug, prompted by its good anti-acidic efficacy and short-term safety profile. Gastric cancer is the 3rd leading cause of cancer-related mortality globally, responsible for 770,000 deaths each year. There are biological mechanisms linking long-term PPI-use with an increased risk of gastric cancer. But existing research has not provided a definite answer to whether long-term PPI-use increases risk of gastric cancer. The literature is hampered by short follow-up time, insufficient statistical power, lack of population-based design and confounding. With the availability of nationwide complete drug registries in the Nordic countries, the first two starting in 1994 (Denmark and Finland), we can now, by adding registry data from all Nordic countries, conduct the first study providing a robust and valid answer to this research question. Overarching aim To clarify if (and if so to what extent) long-term PPI-therapy increases the risk of gastric adenocarcinoma. For validation reasons, we will also examine how long-term use of histamine-2-receptor blockers (H2RB) influences the risk of developing gastric adenocarcinoma. These analyses will validate that the findings are specific for PPIs. H2RB are used for the same indications as PPIs, but with a different biological mechanism. Hypothesis Long-term use of PPI (but not H2RB) increases the risk of gastric adenocarcinoma. Prerequisites This will be the first project with all prerequisites to provide conclusive answers to the hypotheses above, i.e.:

• Long follow-up (up to 28 years)
• Complete follow-up (by virtue of the nationwide complete Nordic registries)
• Population-based design (which rules out biased selection of cases or controls)
• Sufficient statistical power (all five Nordic countries participate with nationwide data)
• High-quality data on exposures, outcomes and confounders (thanks to well-maintained and complete nationwide Nordic health data registries)
• Control for confounding factors (available for all participants, both cases and controls)

Conditions

Cancer of Stomach; Cancer of the Esophagus; Drug Use

Keywords

Gastric cancer; Esophageal cancer; Medications; Case-control study; Nordic

Outcome Measures

Primary Outcomes (1)

• Gastric adenocarcinoma

  Risk of developing gastric adenocarcinoma using logistic regression providing odds ratios

  5 years

Secondary Outcomes (1)

• Esophageal cancer

  5 years

Interventions

Proton pump inhibitor DRUG

Long-term use of medications, particularly proton pump inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cases are patients with a recorded diagnosis of esophageal or gastric tumor. Controls are 10 times as many randomly and frequency-matched people from the background populations.

You may qualify if:

• Diagnosis of esophageal or gastric tumor or frequency matched population control participants

You may not qualify if:

• Age below 18 years

Sponsors & Collaborators

• Karolinska Institutet: lead
• University of Copenhagen: collaborator
• University of Oulu: collaborator
• Norwegian University of Science and Technology: collaborator
• Reykjavik University: collaborator

Study Sites (1)

Karolinska Institutet, Department of Molecular Medicine and Surgery

Stockholm, Please Select (US/Canada Only)..., 171 77, Sweden

Location

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Interventions

Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jesper Lagergren, MD, PhD

  Karolinska Institutet, Department of Molecular Medicine and Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: January 1, 2019
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)