Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT07110259
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 75 years, inclusive, at the time of enrollment.
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with clinical stage II-IV as per the 8th edition of the AJCC staging system.
* Availability of qualified histopathological whole-slide images that can be reviewed through the KindMED system(DeepGEM).
* Successful mutation prediction of EGFR, ALK, or ROS1 by the DeepGEM AI tool.
* No prior systemic anti-cancer therapy, including chemotherapy, targeted therapy, or immunotherapy.
* Willing and able to comply with study requirements, including follow-up and treatment; written informed consent must be provided.
Exclusion Criteria:
* Prior systemic anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy-including but not limited to monoclonal antibodies or tyrosine kinase inhibitors) before enrollment.
* Failure of DeepGEM analysis or unqualified histopathological image quality.
* History of any other malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma (e.g., cervical carcinoma in situ).
* Cognitive or psychological barriers to understanding or accepting AI-based prediction or molecular testing.
* Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraception.
* Any other clinical condition that, in the opinion of the investigators, may interfere with the study protocol or compromise participant safety, including poor compliance with study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07110259
Study Brief:
Protocol Section:
NCT07110259