NSCLC Clinical Trial
Official title:
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)
NCT number | NCT03465241 |
Other study ID # | GASTO1035 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 21, 2017 |
Est. completion date | February 1, 2021 |
Verified date | July 2021 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 119 |
Est. completion date | February 1, 2021 |
Est. primary completion date | February 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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