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LIFE - Lung Cancer, Immunotherapy, Frailty, Effect

NCT03870464 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-05-07

No results posted yet for this study

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.

Conditions

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).

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Odense Patient Data Explorative Network

    collaborator OTHER

  • Region of Southern Denmark

    collaborator OTHER

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Birgitte Bjørnhart, MD · University of Southern Denmark

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2022-11-08
Completion
2028-04-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03870464 on ClinicalTrials.gov