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NCT Number: NCT02645318

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

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

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, 100044, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Whether ctDNA can detect genomic alterations in peripheral blood that are consistent with those in matched tumor sample

    Time frame: 2-3 months

Secondary outcomes

  1. Concordance of tDNA and plasma ctDNA gene detection in early stage non-small cell lung cancer

    Time frame: 2-3months

  2. Correlation of ctDNA concentration with clinical features

    Time frame: 2-3months

  3. Comparison of positive predictive value between ctDNA and tumor markers

    Time frame: 2-3months

  4. The relationship between ctDNA concentration and disease free survival(DFS）

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • University of Southern California

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 1, 2016
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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