Clinical trial · Observational
ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage I NSCLS by NGS
Multicentre, Prospective, Open Clinical Study of Postoperative ctDNA Dynamic Monitoring and Its Role of Prognosis in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)
- 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)
CtDNA detection is a noninvasive detection method, and the second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. This project is to study the role of ctDNA dynamic monitoring of stage I NSCLC by NGS technique to verify the prognostic predictive effect of ctDNA .
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 Stage I | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA detection | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Stage I NSCLC patients after surgery with ctDNA detection
- description
- Stage I NSCLC patients;ctDNA detection
- interventionNames
- Genetic: ctDNA detection
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 2 years after the last patient enrolled
- description
- Disease-free survival was assessed from surgery to disease recurrence or death as a result of any cause
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- 5 years after the last patient enrolled
- description
- Overall survival was assessed from surgery to death as a result of any cause
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 IA / IB NSCLC with R0 resection; * No adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery; General selection criteria: * Men or women of age ≥18 years and \<75 years old; * 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 (1)
- DERIVEDYang W, You N, Jia M, Yeung SJ, Ou W, Yu M, Wang Y, Fu X, Zhang Z, Yang J, Lao Z, Liu Z, Zeng B, Ou Q, Wu X, Shao YW, Hong X, Wang S, Cheng C. Undetectable circulating tumor DNA levels correlate with low risk of recurrence/metastasis in postoperative pathologic stage I lung adenocarcinoma patients. Lung Cancer. 2020 Aug;146:327-334. doi: 10.1016/j.lungcan.2020.06.009. Epub 2020 Jun 20. PMID 32623075