Prognosis prediction and treatment for non-small cell lung cancer using blood tests
Minimal Residual Disease (MRD) Guided Prognosis Prediction and Adjuvant Treatment Based on Expression and Mutational Signatures of Circulating Tumor Cell (CTC) and Circulating Tumor DNA (ctDNA) in Non-small Cell Lung Cancer
This study is trying to see if blood tests can help predict outcomes and guide treatment for patients with stage IIA-IIIC non-small cell lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jiangsu Cancer Institute & Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06198868 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of minimal residual disease (MRD) monitoring in patients with stage IIA-IIIC non-small cell lung cancer (NSCLC) using circulating tumor cells (CTC) and circulating tumor DNA (ctDNA). It is a single-center, prospective cohort study that aims to detect MRD and assess its impact on prognosis and treatment decisions. Patients enrolled will undergo genomic and single-cell RNA sequencing to analyze their CTC and ctDNA. The study focuses on operable or inoperable patients who have not received prior systemic therapy for advanced disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed stage IIA-IIIC NSCLC who have not received prior systemic antitumor therapy.
Not a fit: Patients who have undergone surgical treatment for lung tumors or received neoadjuvant chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment strategies and improved outcomes for patients with NSCLC.
How similar studies have performed: While the use of MRD monitoring in cancer treatment is gaining traction, this specific approach in NSCLC is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Written informed consent must be signed before implementing any enrollment-related procedures; 2. Age ≥18 years old; 3. Patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer, 8th Edition TNM staging)； 4. There is no special restriction on the source of genetic test report. 5. According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one radiographically measurable lesion. 6. Have not received any previous systemic antitumor therapy for advanced diseases. 7. No serious abnormalities of hematopoietic function, heart, lung, liver, kidney function and immune system. 8. ECOG score: 0-1; 9. Expected survival time \> 3 months. Exclusion Criteria: 1. Received surgical treatment for lung tumors. 2. Received neoadjuvant chemotherapy or radiotherapy. 3. Received cellular therapy within the last 1 year. 4. Treated but uncontrolled diabetes, mellitus, asthma, autoimmune diseases and other chronic diseases. 5. Participated in other clinical trials (including research vaccines, drugs, medical devices, etc.) within one month.
Where this trial is running
Nanjing, Jiangsu
- Jiangsu Cancer Institute & Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Rong Yin, M.D., Ph.D.
- Email: rong_yin@njmu.edu.cn
- Phone: 18305185629
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.