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Recruiting NCT05778253

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

— Observational Lung Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: WES and ctDNA detection.
Who it may be relevant to
Registry conditions: Lung Squamous Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Diagnostic test WES and ctDNA detection
    WES and ctDNA detection

Primary outcome measures

  • Pathologic completet response (pCR) rate [Time frame: Up to 1 year]
  • ctDNA resolution [Time frame: Up to 2 years]
  • Development of computer algorithm to identify pCR features [Time frame: From retrospective data collection to algorithm development (6 month)]
  • Validation of computer algorithm to identify pCR features [Time frame: From prospective data collection to algorithm validation (6 months)]
Secondary outcome measures (8)
  • Major pathological response (MPR) rate [Time frame: Up to 1 year]
  • Objective response rate(ORR) [Time frame: Up to 1 year]
  • Adverse events (AEs) [Time frame: Up to 5 years]
  • Perioperative complications rate [Time frame: Up to 3 years]
  • Health-related Quality of Life [Time frame: Up to 5 years]
  • Perioperative pain evaluation [Time frame: Up to 3 years]
  • Disease free survival (DFS) [Time frame: Up to 5 years]
  • Overall survival (OS) [Time frame: Up to 5 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China — Changsha

Identifiers

NCT: NCT05778253 · LYF2022198

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗