ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage I NSCLS by NGS

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Non-small Cell Lung Cancer Stage I

Intervention / Treatment
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* Genetic: ctDNA detection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stage I NSCLC patients after surgery with ctDNA detection<br>Stage I NSCLC patients;ctDNA detection | Genetic: ctDNA detection<br>* To detect ctDNA in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, stage I, The next generation of high-throughput gene sequencing (NGS), ctDNA