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Real-World Insights on Cancer Burden and Treatment Delays – A Comprehensive Observation Study Based on DigiONE Treatment Centres (DigiACT)

Real-World Insights on Cancer Burden and Treatment Delays – A Comprehensive Observation Study Based on DigiONE Treatment Centres (DigiACT) - DigiACT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038678
Enrollment
150000
Registered
2026-03-03
Start date
2026-03-31
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C00-C97

Interventions

Group 1: Retrospective analysis of all adult patients with a primary cancer diagnosis between 01/01/2019 to 31/12/2024.

Sponsors

DigiCore
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of a primary malignancy from a list of SNOMED codes (broadly: primary malignancies except for non-melanoma skin cancer, cancers of unknown primary, and rare subtypes) between 01/01/2019 to 31/12/2024.

Exclusion criteria

Exclusion criteria: - Recorded opt out of their data used for research purposes - Data regarding initial diagnosis, treatment for the primary malignancy, and survival are not available at the participating centre - For the analysis of 12-month survival (objective 3), patients with less than 12 months of follow-up opportunity will be excluded (i.e. index date <12 months prior to data cut)

Design outcomes

Primary

MeasureTime frame
1. To describe the real-world burden of cancer in DigiONE centres by analysing delay from diagnosis to treatment by cancer type across key time intervals (monthly), particularly from the time closest to the index date (index date defined as the patient’s earliest primary cancer diagnosis) to the initiation of first cancer treatment. Data are obtained from OMOP-formatted databases at participating DigiONE cancer centres. Routine clinical information from electronic medical records, including demographic data, clinical characteristics, molecular and genetic biomarkers, treatment details, and in-hospital deaths, is extracted directly or derived from OMOP concepts. Mortality data are supplemented through linkage with regional or national death registries where available, while centres without registry linkage estimate vital status based on in-hospital death records and last consultation dates; concordance between both approaches is assessed in centres with registry access. All analyses are conducted through federated analysis, ensuring that patient-level data remain within each centre and only aggregate results are shared.

Secondary

MeasureTime frame
2. To describe the clinical and demographic characteristics (age, sex, stage of cancer, and history of cancer) of patients with cancer-by-cancer type by index date treated in each participating DigiONE centre, stratified by geographic locations 2a. To describe the number of new cancer diagnoses by cancer type and subtype by index date (by month) across the network of DigiONE centres within the time period from 01/01/2019 to 30/12/2024 3. In patients with 12-month, 24-month, and 36-month follow-up opportunities, to describe the change in 12-month, 24-month, and 36-month survival by cancer type across the network of DigiONE centres and in each participating centre: 3a. To describe the relationship between "the delay from diagnosis to treatment" and 12-month, 24-month, and 36-month survival by cancer type. 3b. To describe the relationship between "number of new cancer diagnosis" and 12-month, 24-month, and 36-month survival by cancer type. 4. To describe the most common cancer types and subtypes within the study cohort and evaluate differences in anticancer treatment types (such as surgery, radiotherapy, and systemic therapies) across these subtypes 5. To describe the molecular and genetic biomarker profile among cancer types and subtypes at participating DigiONE centres closest to the index date 6. To describe the proportion of patients receiving inpatient anticancer treatment at DigiONE centres. 7. To describe the number of scans performed annually by scan type and cancer type.

Countries

Belgium, Czechia, Estonia, Germany, Ireland, Italy, Lithuania, Netherlands, Norway, Poland, United Kingdom

Contacts

Public ContactAlberto Traverso

San Raffaele Hospital

traverso.alberto@hsr.it+39 328 9157128

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026