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Prospective Cohort for Non-Small Cell Lung Cancer (LOOP Trial)
N/A
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 months
Awards & highlights
LOOP Trial Summary
This is an observational, prospective, multicenter study conducted in the US to gather evidence in the context of lung cancer to complement the development of a digital solution. Patients initiating treatment for non-small cell lung cancer (NSCLC) will be prospectively followed to characterize risk factors, signs, and symptoms leading to onset, diagnosis, and treatment of pneumonitis/ILD should it occur.
Eligible Conditions
- Non-Small Cell Lung Cancer
LOOP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and odds ratio (OR) of the algorithm
Secondary outcome measures
Change from baseline in 5 Level EuroQoL 5 Dimension Questionnaire (EQ-5D-5L) health status score
Change from baseline in St George's Respiratory Questionnaire (SGRQ-I) health status score
Change from baseline in symptom severity score
+10 moreLOOP Trial Design
1Treatment groups
Experimental Treatment
Group I: Prospective CohortExperimental Treatment1 Intervention
NSCLC patients initiating an approved treatment with risk of pneumonitis/ILD.
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,606,381 Total Patients Enrolled
Frequently Asked Questions
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