Clinical trial · Observational
Circulating DNA in Surgically Treated NSCLC
Circulating DNA in Non-small Cell Lung Cancer Patients: Relation to Tumor Burden, Disease Prognosis and Risk for Cancer Recurrence, With Emphasis on Tumor Heterogeneity and Treatment Response
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* The investigators will prospectively recruit 100 NSCLC patients. The cfDNA samples will be gathered before the surgery and postoperatively 4-6 weeks after surgery and at 6 and 12 months follow-up visits. * This study aims to investigate the role of ctDNA in NSCLC patients treated with curative intent surgery. * Preoperative ctDNA will be compared to primary tumor DNA to investigate the concordance of mutations and gained mutations from possible primary tumor cancer stem cell. * Preoperative ctDNA findings will be tested for associations with baseline characteristics as well as clinically important factors such as TNM stage, histopathological findings, and tumor volume. * The investigators aim to identify molecular residual disease (MRD) using multiple ctDNA samples after the surgery and search the associations with clinical recurrence and survival, with possible correlation to palliative chemotherapy response * Using multiple ctDNA samples, the investigators will gather information about tumor heterogeneity, diversity of disease genotypes, and dynamic changes in ctDNA. * If additional data from palliative immunotherapy (PD-L1 inhibitors) is available, the effect of this will be evaluated in the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circulating tumor DNA | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 2 years
- description
- Lead time to tumor recurrence detection by blood circulating tumor DNA versus clinical recurrence
Secondary outcomes (4)
- measure
- The concordance of ctDNA and tumor DNA
- timeFrame
- 1year
- description
- The concordance of mutations detected preoperatively in blood comparing to tumor
- measure
- Prognostic impact of ctDNA
- timeFrame
- 4 years
- description
- The correlation of preoperatively or postoperatively collected ctDNA in survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * The inclusion criteria into this study is histologically confirmed NSCLC eligible for surgical treatment and naïve for systemic oncological treatments with either formalin-fixed paraffin-embedded tissue or fresh frozen tissue sample available. Exclusion Criteria: * prior metastatic solid cancer, hematological malignancy, known hereditary cancer syndrome, and pregnancy
References
Publications (0)
Data not yet available