Study type

Study topic

Disease /health condition

Study topic, other

Cancer, thromboembolism

Study type

Non-interventional study

Scope of the study

Disease epidemiology

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Bone cancer
Breast cancer
Colorectal cancer
Leukaemia
Lymphoma
Ovarian cancer
Hepatic cancer
Prostate cancer
Endometrial cancer
Skin cancer
Gastrooesophageal cancer
Pulmonary embolism
Pelvic venous thrombosis
Hepatic vein thrombosis
Retinal vein thrombosis
Disseminated intravascular coagulation

Additional medical condition(s)

Brain cancer, Kidney cancer, Lung cancer, Melanoma, Pancreatic cancer, Venous thromboembolism, Splanchnic vein thrombosis
Population studied

Short description of the study population

The study population will include all individuals aged 18 years and above with a primary diagnosis of selected cancers in the study period. Cancer types will include bone, brain, breast, colorectal, corpus uteri, kidney, leukemia and lymphoma, liver, lung, melanoma, esophageal, ovary, pancreas, prostate, and stomach.

Only patients with the first and one cancer diagnosis (except non-melanoma skin cancer) will be included.
Patients with prior cancer diagnosis (except non-melanoma skin cancer) will be excluded to make sure the outcomes are related to a single primary cancer type of interest patient and also to avoid possible misclassification of second primary cancer and metastatic disease from previously diagnosed primary cancer.

Cancer cases and thromboembolic events will be identified using appropriate computable phenotyping algorithms. Conditions in the OMOP CDM use the Systematised Nomenclature of Medicine (SNOMED) as the standard vocabulary for diagnosis codes.

For cancer diagnoses, the International Classification of Diseases for Oncology, 3rd Edition (ICD-O-3) will also be considered. Algorithms to reproduce cancer phenotypes will be shown along with the study results.

Age groups

Adult and elderly population (≥18 years)
Adults (18 to < 65 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Elderly (≥ 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)
Study design details

Study design

This will be a population-level descriptive epidemiology and patient-level characterisation study.

Main study objective

1. To estimate the incidence rates of thromboembolic events in patients newly diagnosed with each type of selected cancers stratified by country/database, age group, sex, study period (2016-2019 and 2020-2022), and cancer stage one and two years after cancer diagnosis.

2. To characterise cancer patients in terms of demographics, comorbidities and concomitant medication before and at the time of diagnosis, as well as medications and procedures received in the first 90 days after cancer diagnosis.

Setting

This study will use routinely collected health data from 10 databases from 8 European countries.