Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing

Genetic Variations,Immuno-sequencing and Circulating Tumor DNA(ctDNA) for Early Diagnosis of Small Pulmonary Nodules

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03320044

Enrollment

100

Registered

2017-10-24

Start date

2017-10-18

Completion date

2018-12-31

Last updated

2019-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Lung Neoplasm, Non-small-cell Lung Cancer

Keywords

Circulating Tumor DNA, Lung cancer Surgery, early diagnosis, immuno-sequencing

Brief summary

Analyse immune repertoire and genetic mutations of benign and malignant pulmonary nodule，and evaluate peripheral blood detection for identifying nature of pulmonary nodule.

Detailed description

Early diagnosis of lung cancer is of vital importance in lung cancer treatment. This research will first analyse the features of immune repertoire and genetic mutations from tissue of benign and malignant pulmonary nodule，then explore the feasibility of detecting these features from peripheral blood sample, and finally evaluate peripheral blood detection of lung cancer related immune repertoire and genetic mutations for identifying nature of pulmonary nodule.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Sign informed consent and consent to participate in this study; 2. Found small nodules in pulmonary by CT and prepare for surgery;

Exclusion criteria

1. Malignant tumor history within the past 5 years; 2. Receiving chemotherapy, radiotherapy or targeted therapy before surgery; 3. Histology confirmed not non-small cell lung cancer 4. No matching tissue or blood samplesUnqualified blood samples

Design outcomes

Primary

Measure	Time frame
The sensitivity and specificity of combining peripheral plasma circulating tumor DNA and white cell immuno-sequencing in diagnosis of early stage non-small cell lung cancer	6 months

Secondary

Measure	Time frame
The sensitivity and specificity of tissue immune repertoire in diagnosis of early stage non-small cell lung cancer	6 months
The concordance of peripheral plasma circulating tumor DNA and tumor tissue DNA in diagnosis of early stage non-small cell lung cancer	6 months

Countries

China

Outcome results