Clinical trial NCT03465241: ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage II to IIIA NSCLC by NGS
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NSCLC
Keywords: Non-Small Cell Lung Cancer
stage II to IIIA
circulating tumor DNA
The next generation of high-throughput gene sequencing
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 119
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 IIA to IIIA Non-small Cell Lung Cancer (NSCLC) with R0 resection.

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.

Detailed description: In the NGS era, ctDNA detection can truly reflect the real tumor tissue gene mutation map and frequency. It becomes the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after surgery and adjuvant chemotherapy. The second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. The DNA dynamic monitoring of stage II to IIIA non-small cell lung cancer (NSCLC) was performed by the NGS technique to verify prognostic predictive effect of ctDNA in stage IIA to IIIA NSCLC patients after operation. The lung cancer related genes mutation map and frequency between primary tumors and infiltrated regional lymph nodes seems not exactly consistent. In this study, the investigators will compare the lung cancer related genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node by the NGS technique.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free survival
timeFrame: 2 years after the last patient enrolled
Secondary outcomes:
measure: the genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node
timeFrame: one month after the last patient enrolled
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:
citation: 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.