Comparison of Circulating Tumor DNA and Tumor Tissue DNA by Targeted Sequencing in Non-Small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Prospective Study of Circulating Tumor DNA Detection by Targeted Sequencing in Surgical Non-Small Cell Lung Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645318
• Other study ID #: PTHO1501
• Status: Completed
• Phase: N/A
• First received: December 30, 2015
• Last updated: December 30, 2015
• Start date: May 2015
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Conduct a prospective study to compare gene detection by ctDNA with tumor tissue DNA via targeted DNA sequencing in surgical NSCLC patients.

Description:

Previous studies have shown the feasibility of detecting mutation status by circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no clinical standard method has been established, and most previous studies were lack of prospective clinical data and aimed at advanced NSCLC.

We plan to perform a prospective study including consecutive cases of NSCLC patients who underwent surgical treatments. Primary tumor and plasma samples were collected in each patients and gene mutation analysis were performed immediately after surgery. We utilized the targeted DNA sequencing with a next-generation sequencing (NGS) platform to detect driver somatic mutations in matched tumor DNA (tDNA) and plasma ctDNA samples with matched white blood cell (WBC) DNA as a control. A panel of genes were identified.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient who is confirmed primary lung cancer by frozen pathologic histology

• Both the fresh tissue tumor and plasma samples are collected for analysis

Exclusion Criteria:

• Patients who received any treatment prior to resection

• Patients who have a history of malignancy

• Paraffin embedded section confirmed small cell lung cancer or unclassified carcinoma

• Tumor specimens where insufficient DNA

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	University of Southern California

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether ctDNA can detect genomic alterations in peripheral blood that are consistent with those in matched tumor sample		2-3 months	No
Secondary	Concordance of tDNA and plasma ctDNA gene detection in early stage non-small cell lung cancer		2-3months	No
Secondary	Correlation of ctDNA concentration with clinical features		2-3months	No
Secondary	Comparison of positive predictive value between ctDNA and tumor markers		2-3months	No
Secondary	The relationship between ctDNA concentration and disease free survival(DFS)		3 years	No