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

NCT03172156 | Completed DMC

• 1 other identifier: GASTO1018
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 .

Conditions

Non-small Cell Lung Cancer Stage I

Keywords

NSCLC; stage I; The next generation of high-throughput gene sequencing (NGS); ctDNA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall survival

  5 years after the last patient enrolled

Study Arms (1)

Stage I NSCLC patients after surgery with ctDNA detection

Stage I NSCLC patients;ctDNA detection

Genetic: ctDNA detection

Interventions

ctDNA detection GENETIC

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

Stage I NSCLC patients after surgery with ctDNA detection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients With Stage I Non-small Cell Lung Cancer (NSCLC) without Postoperative radiotherapy and chemotherapy

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

Si-Yu Wang

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• 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.

  PMID: 32623075 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

ctDNA of stage I non-small cell lung cancer (NSCLC)

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 1, 2017
• Study Start: July 1, 2017
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: September 4, 2024

Record last verified: 2024-09

Locations

CN (1)