Clinical trial NCT04238130: Evaluation ctDNA in Patients of Non-Small-Cell Lung Cancer Following Resection
Official title: Evaluation Perioperative Dynamic Changes in ctDNA From Patients of Non-Small-Cell Lung Cancer Following Resection for Relapse Prediction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer (NSCLC)
Resectable
Dynamic Monitoring
PEAC
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Hangzhou Repugene Technology Co., Ltd.
First posted: 2020-01-23
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage I to III Non-Small Cell Lung Cancer (NSCLC) with R0 resection

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.

Detailed description: Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. Advances in DNA sequencing technologies and our understanding of the molecular biology of tumours have resulted in increased interest in exploiting ctDNA as a tool to facilitate earlier detection of cancer and thereby improve therapeutic outcomes by enabling early intervention. 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 aim to evaluate whether driver gene mutations detected by PEAC can replace tissue testing results in patients with stage I to Ⅲ NSCLC. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Concordance between genomic alterations assessed by next-generation sequencing in tumor tissue and PEAC technology in circulating tumor DNA
timeFrame: 2 years after the last patient enrolled
measure: ctDNA dynamic monitoring
timeFrame: 2 years after the last patient enrolled
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Si-Yu Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: