The Role of ctDNA Testing Plus AI-based Pathology in Resectable LSCC

Central South University

Status: Enrolling

Conditions: Lung Squamous Cell Carcinoma

Treatments: Diagnostic Test: WES and ctDNA detection

Study type: Observational

Funder types: Other

Identifiers

NCT05778253

LYF2022198

Details and patient eligibility

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.

Full description

This study is a single-center, observational, non-interventional, prospective study. 50 patients diagnosed with lung squamous cell carcinoma receiving neoadjuvant chemoimmunotherapy (ranging 2 to 4 cycles) will be planned to be enrolled in the study. Pre-treatment biopsy tissues of enrolled patients will be collected for whole exon sequencing (WES) testing, and personalized detection panel will be customized based on WES testing results. Peripheral blood will be collected 1 day before each cycle of neoadjuvant therapy, 1 day before surgery, 3 days after surgery, and 3 weeks after surgery for ctDNA testing. In addition, the prediction model of AI-based pathology will be constructed by AI deep learning based on pathological sections of pre-treatment biopsy tissues. All inclued patients will be regularly followed up for at least 5 years.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Patients with lung Squamous Cell Carcinoma receiving neoadjuvant chemoimmunotherapy

Treatment:

Diagnostic Test: WES and ctDNA detection