Using cell-free DNA to detect recurrence in early non-small cell lung cancer
Prospective Feasibility Study of Cell Free Circulating Tumor DNA for the Diagnosis and Treatment Monitoring in Early-stage Non-small Cell Lung Cancer
This study is testing if checking for tumor DNA in the blood can help find out sooner if non-small cell lung cancer comes back after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT03791034 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the role of circulating cell-free tumor DNA (cfDNA) in detecting recurrence of non-small cell lung cancer (NSCLC) after complete surgical resection. By analyzing cfDNA levels in patients who have undergone curative surgery, the study seeks to determine if cfDNA can provide earlier indications of cancer recurrence compared to traditional follow-up methods. Additionally, the genomic signature of cfDNA will be examined to explore its relationship with clinical outcomes in NSCLC patients.
Who should consider this trial
Good fit: Ideal candidates include patients with early-stage non-small cell lung cancer (clinical stage I - IIIA) who have undergone curative resection.
Not a fit: Patients with recurrent lung cancer or those who have received chemotherapy or radiotherapy for non-small cell lung cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of cancer recurrence, potentially improving patient outcomes.
How similar studies have performed: Previous studies have indicated that cfDNA can detect cancer recurrence earlier than conventional methods, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All subjects need to sign the informed consent form * All subjects have Non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively. * Non-small cell lung cancer have to confirmed pathologically after operation * Clinical stage I - IIIA by AJCC 7th staging system Exclusion Criteria: * Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer * Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix with 3 years before enrollment * Recurrent lung cancer * Stage IIIB, IV by AJCC 7th staging system
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Jhingook Kim, MD
- Email: jkimsmc@skku.edu
- Phone: +82-2-3410-3483
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.