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ACTIVE NOT RECRUITING
NCT03870464

LIFE - Lung Cancer, Immunotherapy, Frailty, Effect

Sponsor: University of Southern Denmark

View on ClinicalTrials.gov

Summary

The LIFE study (Lung cancer, Immunotherapy, Frailty, Effect) is investigating the unselected 'real life' non-small cell lung cancer (NSCLC) population treated with immune checkpoint inhibition.

Official title: The Impact of Age and Comorbidity on Effect of Treatment, Adverse Effects and Quality of Life in Danish Lung Cancer Patients Receiving Immunotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2018-04-01

Completion Date

2028-04-01

Last Updated

2024-05-07

Healthy Volunteers

No

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).

Locations (1)

Department of Oncology, Odense University Hospital

Odense, Denmark