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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03172156

Enrollment

100

Registered

2017-06-01

Start date

2017-07-01

Completion date

2020-02-01

Last updated

2024-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer Stage I

Keywords

NSCLC, stage I, The next generation of high-throughput gene sequencing (NGS), ctDNA

Brief summary

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 .

Detailed description

CtDNA detection as a noninvasive detection method, can truly reflect the real tumor tissue gene mutation map and frequency, is the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after treatment. 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. The ctDNA dynamic monitoring of stage I non-small cell lung cancer (NSCLC) was performed by the second generation gene sequencing (NGS) technique to verify the prognostic predictive effect of ctDNA in stage I NSCLC patients without radiotherapy and targeted therapy.

Interventions

GENETICctDNA detection

To detect ctDNA in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Disease-free survival	2 years after the last patient enrolled	Disease-free survival was assessed from surgery to disease recurrence or death as a result of any cause

Secondary

Measure	Time frame	Description
Overall survival	5 years after the last patient enrolled	Overall survival was assessed from surgery to death as a result of any cause

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026