Using ctDNA testing and AI to improve treatment predictions for lung cancer
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)
Run by Second Xiangya Hospital of Central South University · NCT05778253 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Status | Recruiting |
| Started | March 23, 2023 |
| Main results expected | September 23, 2028 |
| Study ends | September 23, 2029 |
| Registry record updated | March 21, 2023 |
| Trial ID | NCT05778253 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
JMT106 injection for advanced solid tumors
This first-in-human Phase 1 trial will try JMT106 injection as a single treatment for adults with advanced solid tumors who have exhausted or do not have standard therapy options.
-
TER-2013 for advanced solid tumors with AKT/PI3K/PTEN pathway changes
This trial tests whether TER-2013, alone or with fulvestrant, is safe and can help people with advanced breast, ovarian, endometrial, lung, or head-and-neck cancers that have AKT/PI3K/PTEN pathway alterations.
-
Observational study on characteristics and outcomes of patients with surgically removed lung cancers
This study looks at patients in China who have had lung cancer surgery to see how their treatment and outcomes vary and what factors might affect their survival.
-
Combining low-dose radiation with immunotherapy and chemotherapy for lung cancer treatment
This study is testing if adding low-dose radiation to standard chemotherapy and a new immune treatment can help people with advanced lung cancer feel better and live longer.
-
Testing AZD5335 for advanced solid tumors
This study is testing a new treatment called AZD5335, alone or with other cancer drugs, to see if it helps people with advanced ovarian cancer and lung adenocarcinoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.