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Completed

NCT Number: NCT03172156

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

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 .

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Si-Yu Wang

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ctDNA detection

Genetic

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

Primary outcomes

  1. Disease-free survival

    Time frame: 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 outcomes

  1. Overall survival

    Time frame: 5 years after the last patient enrolled

    Overall survival was assessed from surgery to death as a result of any cause

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

Registry information

Official study title

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)

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 1, 2017
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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