Clinical trial NCT02645318: Comparison of Circulating Tumor DNA and Tumor Tissue DNA by Targeted Sequencing in Non-Small Cell Lung Cancer
Official title: A Prospective Study of Circulating Tumor DNA Detection by Targeted Sequencing in Surgical Non-Small Cell Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Circulating Tumor DNA
Lung cancer
Targeted sequencing
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern California
First posted: 2016-01-01
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive cases who were suspected of non-small cell lung cancer and underwent curative-intent resection.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Whether ctDNA can detect genomic alterations in peripheral blood that are consistent with those in matched tumor sample
timeFrame: 2-3 months
Secondary outcomes:
measure: Concordance of tDNA and plasma ctDNA gene detection in early stage non-small cell lung cancer
timeFrame: 2-3months
measure: Correlation of ctDNA concentration with clinical features
timeFrame: 2-3months
measure: Comparison of positive predictive value between ctDNA and tumor markers
timeFrame: 2-3months
measure: The relationship between ctDNA concentration and disease free survival(DFS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Kezhong Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University People's Hospital
name: Jun Wang, M.D.
role: STUDY_CHAIR
affiliation: San Valley Biotechnology Incorporated
name: Feng Lou
role: STUDY_DIRECTOR
References: