OPEN Research Support
head

PhD student, MD
Debbie Madsen
Department of Oncology, Odense University Hospital


Projekt styring
Projekt status    Open
 
Data indsamlingsdatoer
Start 01.01.2026  
Slut 31.12.2027  
 



ICiDia - The clinical impact of diabetes on immune checkpoint inhibitor treatment in cancer patients

Short summary

The ICiDia Study investigates how diabetes influences quality of life in cancer patients treated with ICI. A national prospective cohort of 1,000 patients will be established to examine the impact of both pre-existing and treatment-induced diabetes on quality of life. Data are collected before, during, and after treatment to evaluate longitudinal changes in quality of life and assess the occurrence of immune-related diabetes.


Rationale

The aims of the ICiDia Study are to: 1. Compare longitudinal changes in HRQoL between patients with type 2 diabetes and non-diabetic patients during ICI therapy. 2. Estimate the incidence and clinical characteristics of immune-related diabetes in a nationwide, real-world cohort. 3. Assess baseline HRQoL differences between patients with and without pre-existing diabetes, including subtype comparisons (type 1 diabetes and type 2 diabetes). 4. Evaluate HRQoL trajectories in patients with type 1 diabetes and immune-related diabetes during treatment. 5. Explore survival outcomes by diabetes status and subtype over 12 months.


Description of the cohort

The cohort will include 1,000 patients with solid malignant tumours scheduled to receive ICI therapy at the Departments of Oncology at Odense, Aarhus, Aalborg, and Herlev University Hospitals. Patients are recruited from outpatient oncology clinics and followed for 12 months after treatment initiation.


Data and biological material

Questionnaire data and relevant clinical information from medical records will be collected and stored securely using OPEN REDCap and institutional data storage solutions.


Collaborating researchers and departments

Department of Oncology, Aarhus Hospital, Skejby Department of Oncology, Aalborg Hospital Department of Oncology, Herlev Hospital