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

Lung Squamous Cell Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778253
• Other study ID #: LYF2022198
• Status: Recruiting
• Start date: March 23, 2023
• Est. completion date: September 23, 2029

Study information

• Verified date: March 2023
• Source: Second Xiangya Hospital of Central South University
• Contact: Yan Hu, M.D., Ph.D.
• Phone: 8685296122
• Email: yanhu[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 23, 2029
• Est. primary completion date: September 23, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Lung Squamous Cell Carcinoma

Intervention

Diagnostic Test:
• WES and ctDNA detection
WES and ctDNA detection

Locations

Country	Name	City	State
China	Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University	Shanghai OrigiMed Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic completet response (pCR) rate	pCR rate is defined as the percentage of participants having an absence of residual tumor cells in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.	Up to 1 year
Primary	ctDNA resolution	ctDNA resolution is defined as the change or resolution in tumor-derived DNA found in the bloodstream from diagnosis to after neoadjuvant therapy and after surgery, correlated with pathologic complete response (pCR)	Up to 2 years
Primary	Development of computer algorithm to identify pCR features	Development of computer algorithm to identify pCR features	From retrospective data collection to algorithm development (6 month)
Primary	Validation of computer algorithm to identify pCR features	Validation of computer algorithm to identify pCR features	From prospective data collection to algorithm validation (6 months)
Secondary	Major pathological response (MPR) rate	MPR rate is defined as the percentage of participants having =10% viable tumor cells in the resected primary tumor and resected lymph nodes following completion of neoadjuvant therapy.	Up to 1 year
Secondary	Objective response rate(ORR)	The proportion of patients achieved complete or patial remission(Imageological) according to RECIST 1.1 prior to definitive surgery.	Up to 1 year
Secondary	Adverse events (AEs)	Number of participants experiencing AEs will be recorded. An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Up to 5 years
Secondary	Perioperative complications rate	Number of participants experiencing perioperative complications will be recorded.	Up to 3 years
Secondary	Health-related Quality of Life	Health-related Quality of Life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0, the EORTC Quality of Life Questionnaire in Lung Cancer (EORTC QLQ-LC13), and the European Quality of Life 5 Dimensions (EQ-5D) questionnaire.	Up to 5 years
Secondary	Perioperative pain evaluation	Perioperative pain evaluation assessed by a numeric rating scale (NRS)	Up to 3 years
Secondary	Disease free survival (DFS)	From the date of surgery to any of the following events: disease progression, disease recurrence or death from any cause.	Up to 5 years
Secondary	Overall survival (OS)	From the date of participated in study to the date of death.	Up to 5 years