- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06314542
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Restrictive eligibility criteria in cancer drug trials result in low enrollment rates and limited population diversity. Relaxed eligibility criteria (REC) based on solid evidence is becoming necessary for stakeholders worldwide. However, the absence of high-quality, favorable evidence remains a major challenge. This study presents a protocol to quantitatively evaluate the impact of relaxing eligibility criteria in common non-small cell lung cancer (NSCLC) protocols in China, on the risk-benefit profile. This involves a detailed explanation of the rationale, framework, and design of REC.
To evaluate our REC in NSCLC drug trials, we will first construct a structured, cross-dimensional real-world NSCLC database using deep learning methods. We will then establish randomized virtual cohorts and perform benefit-risk assessment using Monte Carlo simulation and propensity matching. Shapley value will be utilized to quantitatively measure the effect of the change of each eligibility criterion on patient volume, clinical efficacy and safety.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ning Li, doctor
- Phone Number: 01087788713
- Email: ncctrials@cicams.ac.cn
Study Locations
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-
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Beijing, China
- Recruiting
- Cancer Hospital, Chinese Academy of Medical Sciences
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Contact:
- Ning li
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients in the database were considered to be part of the real-world cohort if they were (1) diagnosed with NSCLC according to the tenth revision of the international classification of diseases (ICD-10) code; (2) diagnosed with stage IIIB, IIIC, IV NSCLC between 1 January 2013 and 31 December, 2022; (3) had at least two documented clinical visits on or after 1 January 2013.
Exclusion Criteria:
(1)NSCLC in stage I-IIIa
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scale of eligibility criteria
Time Frame: 2024.12.31
|
Lung cancer clinical trial protocol eligibility criteria
|
2024.12.31
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Ning Li, doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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