Radiomics to Identify Patients at Risk for Developing Pneumonitis, Differentiate Immune Checkpoint Inhibitor-induced Pneumonitis From Other Lung Inflammation and Distinguish Tumour Pseudo-progression From Real Tumour Growth
Radiomics to 1. Identify Patients at Risk for Developing Pneumonitis, 2. Differentiate Immune Checkpoint Inhibitor-induced Pneumonitis From Other Lung Inflammation and 3. Distinguish Tumour Pseudo-progression From Real Tumour Growth, in Patients With Non-small Cell Lung Cancer Treated With Anti-PD1 or Anti-PD-L1
1 other identifier
observational
637
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 21, 2017
CompletedFirst Posted
Study publicly available on registry
October 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedSeptember 16, 2021
September 1, 2021
3.3 years
September 21, 2017
September 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cause of pneumonitis
Determining cause of the pneumonitis by medical status of the patient
6 months
Secondary Outcomes (1)
Predictive accuracy of radiomics for determining the cause of pneumonitis
6 months
Study Arms (2)
Patients with a pulmonary event
(under anti-PD1 or anti-PD-L1) This is the first group of the retrospective part of the study.
Patients without a pulmonary event
(under anti-PD1 or anti-PD-L1) This is the second group of the retrospective part of the study.
Interventions
As this is a patient registry, there are no interventions.
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- The opposite of the above
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht Radiation Oncologylead
- Maastricht University Medical Centercollaborator
- Zuyderland Medical Centrecollaborator
Study Sites (2)
Zuyderland Medical Center
Heerlen, 6419 PC, Netherlands
MUMC+
Maastricht, 6229 HX, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dirk De Ruysscher, MD, PhD
Maastro Clinic, The Netherlands
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2017
First Posted
October 10, 2017
Study Start
September 1, 2017
Primary Completion
January 1, 2021
Study Completion
April 1, 2021
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share