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)

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.

Study Overview

• Status: Completed
• Conditions: NSCLC
• Intervention / Treatment: Diagnostic test: the ctDNA dynamic monitoring

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients With Stage IIA to IIIA Non-small Cell Lung Cancer (NSCLC) with R0 resection.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Monitoring by NGS group; 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.	Diagnostic test: the ctDNA dynamic monitoring; To detect ctDNA in patients using the second generation of high-throughput gene sequencing (NGS)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Publications and helpful links

General Publications

• Li 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2017
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer; circulating tumor DNA; stage II to IIIA; The next generation of high-throughput gene sequencing
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: GASTO1035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No