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

NCT03465241 | Completed

• 1 other identifier: GASTO1035
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NSCLC

Keywords

Non-Small Cell Lung Cancer; stage II to IIIA; circulating tumor DNA; The next generation of high-throughput gene sequencing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node

  one month after the last patient enrolled

Study Arms (1)

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

Interventions

the ctDNA dynamic monitoring DIAGNOSTIC_TEST

To detect ctDNA in patients using the second generation of high-throughput gene sequencing (NGS)

Monitoring by NGS group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

Related Publications (1)

• 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.

  PMID: 35076939 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue, lymph node tissue, blood.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Si-Yu Wang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: October 21, 2017
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)