Clinical trial · Observational
ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage II to IIIA NSCLC by NGS
Prospective, Open Clinical Study of Postoperative ctDNA Dynamic Monitoring and Its Role of Prognosis in Patients With Stage II to IIIA 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)
The second generation of high-throughput gene sequencing (NGS) is an important means of detecting the tumor DNA and circulating tumor DNA (ctDNA), which can detect trace ctDNA from smaller plasma samples. This project is chiefly to study the role of ctDNA dynamic monitoring of stage IIA to IIIA NSCLC by NGS technique to verify the prognostic predictive effect of ctDNA. And the investigators also wander the concordance of lung cancer related genes mutation map and frequency between primary tumors and infiltrated regional lymph nodes.
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 |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| the ctDNA dynamic monitoring | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Monitoring by NGS group
- description
- This group will accept the ctDNA dynamic monitoring on the following phase:the day before surgery,the 3rd to 7th day after surgery,3 to 4 weeks after adjuvant chemotherapy finished, then every 6 months in the following 2 years.
- interventionNames
- Diagnostic Test: the ctDNA dynamic monitoring
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
- the genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node
- timeFrame
- one month after the last patient enrolled
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 IIA to IIIA NSCLC with R0 resection; * No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer； * 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 (1)
- DERIVEDLi N, Wang BX, Li J, Shao Y, Li MT, Li JJ, Kuang PP, Liu Z, Sun TY, Wu HQ, Ou W, Wang SY. Perioperative circulating tumor DNA as a potential prognostic marker for operable stage I to IIIA non-small cell lung cancer. Cancer. 2022 Feb 15;128(4):708-718. doi: 10.1002/cncr.33985. Epub 2021 Oct 18. PMID 35076939