Evaluation ctDNA in Patients of Non-Small-Cell Lung Cancer Following Resection

NCT04238130 | Completed

• 1 other identifier: GASTO1058
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. In this study, PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. Investigators also applied ctDNA dynamic monitoring using PEAC technology in early stage NSCLC patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer (NSCLC); Resectable; Dynamic Monitoring; PEAC

Outcome Measures

Primary Outcomes (2)

• Concordance between genomic alterations assessed by next-generation sequencing in tumor tissue and PEAC technology in circulating tumor DNA

  PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline.

  2 years after the last patient enrolled

• ctDNA dynamic monitoring

  PEAC technology was performed to apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline

  2 years after the last patient enrolled

Study Arms (1)

Perioperative ctDNA Dynamic Monitoring Group

Samples were obtained at multiple pre-specified time points including before surgery (plasma samples)，during surgery after tumor resection (tumor samples) and after surgery(plasma samples were obtained every 6 months from ctDNA positive patients at baseline in the following 2 years)

Diagnostic Test: Perioperative ctDNA Dynamic Monitoring

Interventions

Perioperative ctDNA Dynamic Monitoring DIAGNOSTIC_TEST

To apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline

Perioperative ctDNA Dynamic Monitoring 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 I to III Non-Small Cell Lung Cancer (NSCLC) with R0 resection

You may qualify if:

• Postoperative histopathological diagnosis of TNM stage I to III NSCLC with R0 resection;
• No adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery;
• Men or women of age ≥18 years and \<75 years old;
• 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
• Hangzhou Repugene Technology Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor Tissue, Whole 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: January 17, 2020
• First Posted: January 23, 2020
• Study Start: December 18, 2019
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

CN (1)