Using ctDNA testing and AI to improve treatment predictions for lung cancer
Circulating Tumor DNA (ctDNA) Dynamic Monitoring Plus Artificial Intelligence (AI)-Based Pathology Predict the Efficacy of Chemoimmunotherapy in Resectable Lung Squamous Cell Carcinoma (LSCC)
This study is testing if using blood tests for tumor DNA along with AI can help doctors better predict how well a new treatment works for patients with lung cancer that can be surgically removed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05778253 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine if dynamic monitoring of circulating tumor DNA (ctDNA) combined with AI-based pathology can better predict the effectiveness of neoadjuvant chemoimmunotherapy in patients with resectable lung squamous cell carcinoma. It will enroll 50 patients who will undergo whole exon sequencing of biopsy tissues and regular ctDNA testing throughout their treatment. The study will also develop an AI model based on pathological data to enhance treatment guidance. Participants will be followed for at least five years to assess long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with stage II-IIIb resectable lung squamous cell carcinoma who have not received prior treatment.
Not a fit: Patients with unresectable tumors, non-squamous non-small cell lung cancer, or those who have previously received immune checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate treatment predictions and improved outcomes for patients with lung squamous cell carcinoma.
How similar studies have performed: While the combination of ctDNA monitoring and AI-based pathology is a novel approach, similar studies have shown promise in improving treatment predictions in oncology.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Changsha, Hunan
- Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Yan Hu, M.D., Ph.D.
- Email: yanhu@csu.edu.cn
- Phone: 8685296122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.