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

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

NCT ID: NCT05778253

Condition: Lung Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: WES and ctDNA detection
Description: WES and ctDNA detection
Arm group label: Patients with lung Squamous Cell Carcinoma receiving neoadjuvant chemoimmunotherapy

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.

Detailed 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.

Criteria for eligibility:

Study pop:
Resectable or potentially resectable stage II-IIIb lung squamous cell carcinoma patients receiving neoadjuvant chemoimmunotherapy

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

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

Address:
City: Changsha
Zip: 410011
Country: China

Status: Recruiting

Contact:
Last name: Yan Hu, M.D., Ph.D.
Email: yanhu@csu.edu.cn

Start date: March 23, 2023

Completion date: September 23, 2029

Lead sponsor:
Agency: Second Xiangya Hospital of Central South University
Agency class: Other

Collaborator:
Agency: Shanghai OrigiMed Co., Ltd.
Agency class: Other

Source: Second Xiangya Hospital of Central South University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05778253