An observational study in Stage IV Non-small Cell Lung Cancer, sponsored by Maastricht Radiation Oncology. Completed at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Maastricht Radiation Oncology · Observational
The investigators will develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40 patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls).
On the basis of the case-control study of patients treated with anti-PD1 or anti-PD-L1, they will further optimise the model using reinforcement machine learning. The model will then be validated in 300 prospective patients.
Preliminary analyses on a dataset showed a clear distinction in radiomics features for patients with and without pneumonitis from anti-PD1 or anti-PD-L1. Prior experience of the investigators of training and validating radiomics signatures combined with their preliminary exploratory results presented here, will be used to develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40 patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls).
On the basis of the case-control study of patients treated with anti-PD1 or anti-PD-L1, the investigators will be able to further optimise the model using reinforcement machine learning. The model will then be validated in 300 prospective patients.
Patients who receive standard anti-PD1 or anti-PD-L1 treatment in routine clinical practice for first or second line stage IV non-small cell lung cancer
Exclusion Criteria:
(under anti-PD1 or anti-PD-L1) This is the first group of the retrospective part of the study.
Other: No interventions
(under anti-PD1 or anti-PD-L1) This is the second group of the retrospective part of the study.
Other: No interventions
As this is a patient registry, there are no interventions.
Cause of pneumonitis
Determining cause of the pneumonitis by medical status of the patient
Time frame: 6 months
Predictive accuracy of radiomics for determining the cause of pneumonitis
Three subgroups of immune checkpoint induced pneumonitis: 1. Immune checkpoint-induced pneumonitis from tumour progression 2. Immune checkpoint-induced pneumonitis from other types of pneumonitis 3. Patients with interstitial lung disease that are at risk to develop immune checkpoint-induced pneumonitis and those who are not. Radiomics will be used to predict the cause of pneumonitis
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Maastricht Radiation Oncology