Status:
RECRUITING
ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC
Lead Sponsor:
Fang Wu
Collaborating Sponsors:
Sun Yat-sen University
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Advanced Lung Non-Small Cell Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
This study aims to explore the correlation of circulating tumor DNA(ctDNA) and the risk of progression in patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 ...
Detailed Description
Evidence suggests that circulating tumor DNA (ctDNA) analysis can noninvasively identify minimal residual disease (MRD) in clinical oncology. The researches will be sharply increased about ctDNA poten...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Advanced non-small cell lung cancer (stage IIIB-IV), pathological types limited to squamous cell carcinoma or non-squamous cell carcinoma, driver gene mutations (EGFR/ALK/ROS1) were negative
- General condition: ECOG score 0 or 1
- First-line monotherapy or combination immunotherapy
- The long-term benefit of immunotherapy was defined as PFS=12months
- Tumor tissue samples can be obtained at the time of enrollment, and at least 5 \~ 10 sections can be generated, and the pathological report indicates that the overall tumor content is not less than 10% or NGS testing with a fixed-panel is available; or no tumor tissue is available.
- At least one measurable lesion (except patients with CR after first-line treatment) can be evaluated according to RECIST1.1 standard.
- Have self-awareness, be able to understand the research scheme and voluntarily participate in the study, and can sign the informed consent form
- Have good compliance, be able to cooperate with the collection of specimens from each node and provide corresponding clinical information.
Exclusion
- Serious primary diseases of the heart, liver and kidney
- Other malignant tumors within 3 years prior to diagnosis of NSCLC
- Women in pregnancy and lactation
- The active stage of human immunodeficiency virus (HIV) infection
- Patients with active systemic infection, pneumonia, tuberculosis, pericarditis
- Patients who cannot understand the content of the experiment and cannot cooperate and refuse to sign informed consent.
Key Trial Info
Start Date :
January 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05198154
Start Date
January 24 2022
End Date
December 30 2025
Last Update
April 23 2025
Active Locations (1)
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1
Oncology Department，Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011