The Role of ctDNA Testing Plus AI-based Pathology in Resectable LSCC
Recruiting · NCT05778253 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
WES and ctDNA detection
What this trial is about
The goal of this observational study is to explore whether ctDNA dynamic monitoring plus AI-based pathology can more effectively predict the therapeutic effect of neoadjuvant chemoimmunotherapy for resectable lung squamous cell carcinoma, so as to accurately guide clinical diagnosis and treatment.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Histopathology or cytology confirmed the lung squamous cell carcinoma
- Age ranging from 18 to 75
- Agree to participate in this study and sign an informed consent form
- Treatment-naive tumor
- According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage II-IIIb resectable or potentially resectable tumor
- Sufficient tissue/blood samples are available to meet research requirements
- The ECOG PS score is 0-1
Exclusion criteria
- Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
- Non-squamous NSCLC
- Unresectable IIIa-IIIb tumor
- Patients with solid organ or blood system transplantation
- Previous use of CTLA-4, PD-1, or PD-L1 immune checkpoint inhibitors
- Patients with interstitial lung disease
- Patients with acute or chronic infectious disease
- Pregnant and lactating women
- Patients who have undergone other clinical drug trials
Where it is running
1 location listed.
- Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China - Changsha, Hunan, China