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NCT Number: NCT05778253

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

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.

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Key information

Conditions

Lung Squamous Cell Carcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Changsha, Hunan, 410011, China

Location status: Recruiting

Location contact

Yan Hu, M.D., Ph.D.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WES and ctDNA detection

Diagnostic Test

WES and ctDNA detection

Primary outcomes

  1. Pathologic completet response (pCR) rate

    Time frame: Up to 1 year

    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.

  2. ctDNA resolution

    Time frame: Up to 2 years

    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)

  3. Development of computer algorithm to identify pCR features

    Time frame: From retrospective data collection to algorithm development (6 month)

    Development of computer algorithm to identify pCR features

  4. Validation of computer algorithm to identify pCR features

    Time frame: From prospective data collection to algorithm validation (6 months)

    Validation of computer algorithm to identify pCR features

Secondary outcomes

  1. Major pathological response (MPR) rate

    Time frame: Up to 1 year

    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.

  2. Objective response rate(ORR)

    Time frame: Up to 1 year

    The proportion of patients achieved complete or patial remission(Imageological) according to RECIST 1.1 prior to definitive surgery.

  3. Adverse events (AEs)

    Time frame: Up to 5 years

    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.

  4. Perioperative complications rate

    Time frame: Up to 3 years

    Number of participants experiencing perioperative complications will be recorded.

  5. Health-related Quality of Life

    Time frame: Up to 5 years

    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.

  6. Perioperative pain evaluation

    Time frame: Up to 3 years

    Perioperative pain evaluation assessed by a numeric rating scale (NRS)

  7. Disease free survival (DFS)

    Time frame: Up to 5 years

    From the date of surgery to any of the following events: disease progression, disease recurrence or death from any cause.

  8. Overall survival (OS)

    Time frame: Up to 5 years

    From the date of participated in study to the date of death.

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Hu, M.D., Ph.D.

CONTACT

[email protected]

8685296122

Sponsors and collaborators

Lead sponsor

Second Xiangya Hospital of Central South University

Other

Collaborators

  • Shanghai OrigiMed Co., Ltd.

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Mar 21, 2023
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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