Official Title
Evaluation Perioperative Dynamic Changes in ctDNA From Patients of Non-Small-Cell Lung Cancer Following Resection for Relapse Prediction
Brief Title
Evaluation ctDNA in Patients of Non-Small-Cell Lung Cancer Following Resection
Protocol ID
NCT04238130
Lead Sponsor
Sun Yat-sen University
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.
Study Period
-
Enrollment Count
132 participants
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.
Filters
Non-small Cell Lung Cancer
COMPLETED
ADULT
OLDER_ADULT