Clinical trial · Observational
Evaluation ctDNA in Patients of Non-Small-Cell Lung Cancer Following Resection
Evaluation Perioperative Dynamic Changes in ctDNA From Patients of Non-Small-Cell Lung Cancer Following Resection for Relapse Prediction
- 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)
Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. In this study, PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. Investigators also applied ctDNA dynamic monitoring using PEAC technology in early stage NSCLC patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.
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 |
|---|---|---|---|
| Perioperative ctDNA Dynamic Monitoring | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Perioperative ctDNA Dynamic Monitoring Group
- description
- Samples were obtained at multiple pre-specified time points including before surgery (plasma samples)，during surgery after tumor resection (tumor samples) and after surgery(plasma samples were obtained every 6 months from ctDNA positive patients at baseline in the following 2 years)
- interventionNames
- Diagnostic Test: Perioperative ctDNA Dynamic Monitoring
Primary outcomes (2)
- measure
- Concordance between genomic alterations assessed by next-generation sequencing in tumor tissue and PEAC technology in circulating tumor DNA
- timeFrame
- 2 years after the last patient enrolled
- description
- PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline.
- measure
- ctDNA dynamic monitoring
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Postoperative histopathological diagnosis of TNM stage I to III NSCLC with R0 resection; * No adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery; * Men or women of age ≥18 years and \<75 years old; * Eastern Cooperative Oncology Group (ECOG) behavior status score 0 to 1. Exclusion Criteria: * Patients with other cancers other than NSCLC within five years prior to this study; * Who can not get enough tumor histological specimens (non-cytological) for analysis; * Human immunodeficiency virus (HIV) infection; * NSCLC mixed with patients with small cell lung cancer; * Pregnant or lactating women; * There is a clear history of neurological or mental disorders, including epilepsy or dementia; * Conditions that investigators think is not suitable for inclusion.
References
Publications (0)
Data not yet available