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NCT Number: NCT03465241

ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage II to IIIA NSCLC by NGS

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

About this study

In the NGS era, ctDNA detection can truly reflect the real tumor tissue gene mutation map and frequency. It becomes the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after surgery and adjuvant chemotherapy. 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 DNA dynamic monitoring of stage II to IIIA non-small cell lung cancer (NSCLC) was performed by the NGS technique to verify prognostic predictive effect of ctDNA in stage IIA to IIIA NSCLC patients after operation. The lung cancer related genes mutation map and frequency between primary tumors and infiltrated regional lymph nodes seems not exactly consistent. In this study, the investigators will compare the lung cancer related genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node by the NGS technique.

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 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.

Treatment and study plan

the ctDNA dynamic monitoring

Diagnostic Test

To detect ctDNA in patients using the second generation of high-throughput 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. the genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node

    Time frame: one month after the last patient enrolled

    we will compare the lung cancer related genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node by the NGS technique.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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)

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 14, 2018
Registry last updated
Jul 30, 2021

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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