RecruitingNCT05778253

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

Circulating Tumor DNA (ctDNA) Dynamic Monitoring Plus Artificial Intelligence (AI)-Based Pathology Predict the Efficacy of Chemoimmunotherapy in Resectable Lung Squamous Cell Carcinoma (LSCC)

Sponsor

Second Xiangya Hospital of Central South University

Enrollment

50 participants

Start Date

Mar 23, 2023

Study Type

OBSERVATIONAL

Conditions

Lung Squamous Cell Carcinoma

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria9

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

Interventions

DIAGNOSTIC_TESTWES and ctDNA detection

WES and ctDNA detection

Locations(1)

Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China

Changsha, Hunan, China

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NCT05778253

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