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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест WES and ctDNA detection
  WES and ctDNA detection

Первичные конечные точки

• Pathologic completet response (pCR) rate [Срок оценки: Up to 1 year]
• ctDNA resolution [Срок оценки: Up to 2 years]
• Development of computer algorithm to identify pCR features [Срок оценки: From retrospective data collection to algorithm development (6 month)]
• Validation of computer algorithm to identify pCR features [Срок оценки: From prospective data collection to algorithm validation (6 months)]

Вторичные конечные точки (8)

• Major pathological response (MPR) rate [Срок оценки: Up to 1 year]
• Objective response rate(ORR) [Срок оценки: Up to 1 year]
• Adverse events (AEs) [Срок оценки: Up to 5 years]
• Perioperative complications rate [Срок оценки: Up to 3 years]
• Health-related Quality of Life [Срок оценки: Up to 5 years]
• Perioperative pain evaluation [Срок оценки: Up to 3 years]
• Disease free survival (DFS) [Срок оценки: Up to 5 years]
• Overall survival (OS) [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

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

Идентификаторы

NCT: NCT05778253 · LYF2022198

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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