ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage I NSCLS by NGS

NCT ID: NCT03172156

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2020-02-01

Brief Summary

CtDNA detection is a noninvasive detection method, and 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. This project is to study the role of ctDNA dynamic monitoring of stage I NSCLC by NGS technique to verify the prognostic predictive effect of ctDNA .

Detailed Description

CtDNA detection as a noninvasive detection method, can truly reflect the real tumor tissue gene mutation map and frequency, is the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after treatment. 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 ctDNA dynamic monitoring of stage I non-small cell lung cancer (NSCLC) was performed by the second generation gene sequencing (NGS) technique to verify the prognostic predictive effect of ctDNA in stage I NSCLC patients without radiotherapy and targeted therapy.

Conditions

Non-small Cell Lung Cancer Stage I

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stage I NSCLC patients after surgery with ctDNA detection

Stage I NSCLC patients;ctDNA detection

ctDNA detection

Intervention Type: GENETIC

To detect ctDNA in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)

Interventions

ctDNA detection

To detect ctDNA in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• Postoperative histopathological diagnosis of TNM stage IA / IB NSCLC with R0 resection;
• No adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery;

General selection criteria:

• Men or women of age ≥18 years and <75 years old;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Si-Yu Wang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Si-Yu Wang

Guangzhou, Guangdong, China

Countries

China

References

Yang W, You N, Jia M, Yeung SJ, Ou W, Yu M, Wang Y, Fu X, Zhang Z, Yang J, Lao Z, Liu Z, Zeng B, Ou Q, Wu X, Shao YW, Hong X, Wang S, Cheng C. Undetectable circulating tumor DNA levels correlate with low risk of recurrence/metastasis in postoperative pathologic stage I lung adenocarcinoma patients. Lung Cancer. 2020 Aug;146:327-334. doi: 10.1016/j.lungcan.2020.06.009. Epub 2020 Jun 20.

Reference Type: DERIVED

PMID: 32623075 (View on PubMed)

Other Identifiers

GASTO1018

Identifier Type: -

Identifier Source: org_study_id