RecruitingNCT06314542

Quantitative Evaluation of the Impact of Relaxing Eligibility Criteria for Lung Cancer Based on Real-world Data

Quantitative Evaluation of the Impact of Relaxing Eligibility Criteria on the Risk-benefit Profile of Drugs for Lung Cancer Based on Real-world Data


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

50,000 participants

Start Date

Jan 1, 2013

Study Type

OBSERVATIONAL

Conditions

Summary

Eligibility criteria for cancer drug trials are generally too stringent, leading to key issues such as low enrolment rates and lack of population diversity. In order to evaluate the REC of NSCLC drug trials, this study will use deep learning methods to construct a structured real-world database of NSCLC across dimensions, and quantitatively assess the independent contribution of changes in each eligibility criterion to patient numbers, clinical efficacy and safety.


Eligibility

Plain Language Summary

Simplified for easier understanding

This is a real-world data analysis study (not a treatment trial) that examines whether loosening the standard eligibility criteria used in lung cancer clinical trials would allow more patients to participate and still produce valid results. Researchers look at a database of patients with advanced non-small cell lung cancer (NSCLC) to simulate what would happen if stricter inclusion rules were relaxed. **You may be eligible if...** - You are a patient in a real-world clinical database with a confirmed diagnosis of NSCLC (stage IIIB, IIIC, or IV) based on ICD-10 coding - You were diagnosed between January 2013 and December 2022 - You had at least two documented clinical visits after January 2013 **You may NOT be eligible if...** - Your NSCLC is stage I, II, or IIIA (only later stages are included) - Your records do not meet the minimum documentation requirements in the database Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

OTHERrelaxing eligibility criteria

Quantitative evaluation of the impact of relaxing eligibility criteria on the risk-benefit profile of drugs for lung cancer based on real-world data


Locations(1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

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NCT06314542


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