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

NCT06314542 | Recruiting

• 1 other identifier: REC-001
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Scale of eligibility criteria

  Lung cancer clinical trial protocol eligibility criteria

  2024.12.31

Interventions

relaxing eligibility criteria OTHER

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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Those patients diagnosed with primary NSCLC in stage IIIb-IV, are the study population.

You may qualify if:

• 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.

You may not qualify if:

• （1）NSCLC in stage I-IIIa

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• AstraZeneca: collaborator

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ning Li, doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Ning Li, doctor

CONTACT

01087788713; ncctrials@cicams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: January 1, 2013
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

CN (1)