LIFE - Lung Cancer, Immunotherapy, Frailty, Effect

Active, not recruitingOBSERVATIONAL
Enrollment

150

Participants

Timeline

Start Date

April 1, 2018

Primary Completion Date

November 8, 2022

Study Completion Date

April 1, 2028

Conditions
Non-small Cell Lung CancerQuality of LifeBrain MetastasesVenous Thromboembolism
Interventions
DIAGNOSTIC_TEST

CT-scans extended

CT scans of thorax, abdomen and lower extremities are performed - screening for venous trombolisms at baseline and at 6 months in each patient. If VTE is diagnosed, medications according to guidelines will be administered.

DIAGNOSTIC_TEST

MRI scan of the brain

MRI scan of the brain screening for brain metastases. If brain metastases are diagnosed - the possibility of giving radiotherapy along the course of ICI is discussed with the patient. In case of brain metastases consecutive MRI scans of the brain will be performed in order to follow the course (natural or post-radiotherapy) of the disease.

OTHER

Prospective registration of irAEs

irAEs are registered according to Common Terminology Criteria for Adverse Events version 4.0 by a medical doctor or trained experienced clinical nurse.

BEHAVIORAL

Quality of Life questionnaires

Participants fill out two Quality of Life questionnaires. The European Organization of Research and Treatment of Cancer, Quality of Life -30 questionnaire (EORTC QoL-30) and the European Questionnaire - 5 dimensions-5-level questionnaire (Euro EQ-5D-5L).

Trial Locations (1)

5000

Department of Oncology, Odense University Hospital, Odense

All Listed Sponsors
collaborator

Odense University Hospital

OTHER

collaborator

University of Copenhagen

OTHER

collaborator

Odense Patient Data Explorative Network

OTHER

collaborator

Region of Southern Denmark

OTHER

lead

University of Southern Denmark

OTHER

NCT03870464 - LIFE - Lung Cancer, Immunotherapy, Frailty, Effect | Biotech Hunter | Biotech Hunter