Clinical trial NCT05778253: The Role of ctDNA Testing Plus AI-based Pathology in Resectable LSCC
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Squamous Cell Carcinoma
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Shanghai OrigiMed Co., Ltd.
First posted: 2023-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Resectable or potentially resectable stage II-IIIb lung squamous cell carcinoma patients receiving neoadjuvant chemoimmunotherapy

Brief 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.

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

Primary outcomes:
measure: Pathologic completet response (pCR) rate
timeFrame: Up to 1 year
measure: ctDNA resolution
timeFrame: Up to 2 years
measure: Development of computer algorithm to identify pCR features
timeFrame: From retrospective data collection to algorithm development (6 month)
measure: Validation of computer algorithm to identify pCR features
timeFrame: From prospective data collection to algorithm validation (6 months)
Secondary outcomes:
measure: Major pathological response (MPR) rate
timeFrame: Up to 1 year
measure: Objective response rate(ORR)
timeFrame: Up to 1 year
measure: Adverse events (AEs)
timeFrame: Up to 5 years
measure: Perioperative complications rate
timeFrame: Up to 3 years
measure: Health-related Quality of Life
timeFrame: Up to 5 years
measure: Perioperative pain evaluation
timeFrame: Up to 3 years
measure: Disease free survival (DFS)
timeFrame: Up to 5 years
measure: Overall survival (OS)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China
state: Hunan
Study officials:
References: